Tissue anchoring system and method

ABSTRACT

A method for securing an implant to tissue of a patient using a fixation apparatus and a delivery apparatus releasably carrying the fixation apparatus. The fixation apparatus includes first and second anchors and an adjustable band connecting the anchors. The band includes a cinch line and a tether connected to one of the anchors. The delivery apparatus includes a body, a tubular shaft, a displacement rod within the tubular shaft, and an actuator. The method comprises positioning the implant in proximity to the tissue, deploying the anchors into or through the tissue, and applying tension to the cinch line to foreshorten the adjustable band and secure the implant to the tissue with at least a portion of the implant positioned between the band and the tissue.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 11/527,903, filed Sep. 26, 2006, which is acontinuation-in-part of U.S. patent application Ser. No. 11/120,750,filed May 3, 2005, now U.S. Pat. No. 7,615,076, issued Nov. 10, 2009,which is a continuation-in-part of U.S. patent application Ser. No.10/352,981, filed Jan. 29, 2003 and Ser. No. 10/327,106, filed Dec. 24,2002, now U.S. Pat. No. 7,004,970, issued Feb. 28, 2006, each of whichare continuations-in-part of U.S. patent application Ser. No.10/133,339, filed Apr. 29, 2002, now U.S. Pat. No. 7,052,516, issued May30, 2006, and claims, through U.S. patent application Ser. No.10/133,339, now U.S. Pat. No. 7,052,516, issued May 30, 2006, thebenefit of U.S. Provisional Application Ser. No. 60/309,105 filed Jul.31, 2001. U.S. Pat. No. 7,052,516 claims the benefit to and is acontinuation-in part of U.S. patent application Ser. No. 10/075,615filed Feb. 15, 2002, now abandoned, which is a continuation-in-part ofU.S. patent application Ser. No. 09/947,078, filed Sep. 5, 2001, nowU.S. Pat. No. 6,592,625, issued Jul. 15, 2003. which is a continuationof U.S. patent application Ser. No. 09/484,706 filed Jan. 18, 2000, nowabandoned, which claims the benefit to U.S. Provisional PatentApplication Ser. No. 60/160,710, filed Oct. 20, 1999. Each of thepreceding patents and patent applications is incorporated herein byreference in its entirety.

TECHNICAL FIELD

The present inventions relate to medical devices and, more particularly,to devices and methods for the closure, sealing, repair, reconstructionor otherwise treatment of an intervertebral disc.

BACKGROUND

The spinal column is formed from a number of bony vertebrae, which intheir normal state are separated from each other by intervertebraldiscs. The intervertebral disc acts in the spine as a crucialstabilizer, and as a mechanism for force distribution between adjacentvertebral bodies. Without a competent disc, collapse of theintervertebral disc may occur, contributing to abnormal joint mechanicsand premature development of degenerative and/or arthritic changes.

The normal intervertebral disc has an outer ligamentous ring called theannulus fibrosus surrounding the nucleus pulposus. The annulus fibrosusbinds the adjacent vertebrae together and is constituted of collagenfibers that are attached to the vertebrae and cross each other so thathalf of the individual fibers will tighten as the vertebrae are rotatedin either direction, thus resisting twisting or torsional motion. Thenucleus pulposus is constituted of soft tissue, having about 85% watercontent, which moves about during bending from front to back and fromside to side.

The aging process contributes to gradual changes in the intervertebraldiscs. The annulus fibrosus loses much of its flexibility andresilience, becoming more dense and solid in composition. The agingannulus fibrosus may also be marked by the appearance or propagation ofcracks or fissures in the annular wall. Similarly, the nucleusdesiccates, increasing viscosity and thus losing its fluidity. Incombination, these features of the aged intervertebral discs result inless dynamic stress distribution because of the more viscousnucleuspulposus, and less ability to withstand localized stresses by theannulus fibrosus due to its desiccation, loss of flexibility and thepresence of fissures. Fissures can also occur due to disease or otherpathological conditions. Occasionally fissures may form rents throughthe annular wall. In these instances, the nucleus pulposus is urgedoutwardly from the disc space through a rent, often into the spinalcolumn. Extruded nucleus pulposus can, and often does, mechanicallypress on the spinal cord or spinal nerve rootlet. This painful conditionis clinically referred to as a ruptured or herniated disc.

In the event of the rupture of the annulus fibrosus, the subannularnucleus pulposus may migrate along the path of least resistance into thefissure forcing the fissure to open further. The increased size of thefissure can allow the migration of the nucleus pulposus through the wallof the disc. The migration of the nucleus pulposus may result in nervecompression and/or the introduction of inflammatory compounds into thespace around the adjacent nerve roots. This compression and/orintroduction of inflammatory compounds in the lumbar spine may adverselyaffect the nerves associated with the extremities, bladder, bowel andgenitalia. The usual effect of nerve compression and/or inflammation inthis region of the spine is intolerable back or neck pain, radiatinginto the extremities, with accompanying numbness, weakness, and in latestages, paralysis and muscle atrophy, and/or bladder and bowelincontinence. Additionally, injury, disease or other degenerativedisorders may cause one or more of the intervertebral discs to shrink,collapse, deteriorate or become displaced, herniated, or otherwisedamaged and compromised.

Surgical repairs or replacements of displaced or herniated discs areattempted approximately 390,000 times in the USA each year.Historically, there has been no known way to repair or reconstruct theannulus. Instead, surgical procedures to date are designed to relievesymptoms by removing unwanted disc fragments and relieving nervecompression. While results are currently acceptable, they are notoptimal. Various authors report 3.1-21% recurrent disc herniation,representing a failure of the primary procedure and requiringre-operation for the same condition. An estimated 10% recurrence rateresults in 39,000 re-operations in the United States each year.

Some have also suggested that the repair of a damaged intervertebraldisc might include the augmentation of the nucleus pulposus, and variousefforts at nucleus pulposus replacement have been reported. It isbelieved that nucleus replacement technologies may be enhanced throughthe use of complimentary annular repair. Furthermore, it is believedthat various interbody technologies may be more readily sealed withinthe disc space through the repair of annular defects. Finally, annularrepair may be utilized as a vehicle to deliver other reparativematerials to the intervertebral disc space.

SUMMARY

An aperture or hole in the annulus may be a result of a surgicalincision or dissection into the intervertebral disc annulus, or theconsequence of a naturally occurring tear (rent). The effects of annulardefect reconstruction is restoration of disc wall integrity, which mayreduce the failure rate (3-21%) of a common surgical procedure (discfragment removal or discectomy), or advantageously provide a barrier tointradiscal material migration.

Fixation apparatuses and related methods in accordance with the presentinventions may resolve many of the needs and shortcomings discussedabove and provide additional improvements and advantages as will berecognized by those skilled in the art upon review of the presentdisclosure. The inventions may comprise delivery tools for deliveringfixation apparatus 100 and treatment devices 600, as well as kitscomprising devices and tools. The present inventions provide fixationapparatuses 100 and patch-like devices 600 and related methods forrepair, reapproximation, reinforcement, reconstruction or otherwisetreatment of an intervertebral disc in cases of displaced, herniated,thinned, ruptured, or otherwise damaged or infirmed intervertebraldiscs. In accordance with the inventions, methods are disclosed fortreating an intervertebral disc having an aperture, weakened or thinportion in the wall of the annulus fibrosus. Repair, reconstruction,sealing, occluding an aperture, weakened or thin portion in the wall ofthe annulus using apparatuses and methods in accordance with the presentinventions may prevent or avoid migration of intradiscal material fromthe disc space.

Although much of the discussion is directed toward the repair of theintervertebral disc after a surgical procedure, such as discectomy (asurgical procedure performed to remove herniated fragments of the discnucleus), it is contemplated that the devices of the present inventionsmay be used in other procedures that involve access (whether induced ornaturally occurring) through the annulus of the intervertebral disc, orprophylactic application to the annulus. An example of another procedurethat could require a repair technique involves the replacement of thenucleus (nucleus replacement) with an implantable nucleus material toreplace the functioning of the natural nucleus when it is degenerated.In this case, the repair could maintain the replacement nucleus withinthe disc space.

Furthermore, it should be noted that surgeons differ in their techniquesand methods in performing an intervention on a spinal disc, and theinventive descriptions and depictions of methods, devices and deliverytools to repair annular tissue could be employed with a variety ofsurgical techniques; such as, but not limited to: open surgical,microsurgical discectomy (using a magnifying scope or loupes), minimallyinvasive surgical (through, for example, a METRx™ system available fromMedtronic, Inc.), and percutaneous access. Surgeons may also employ avariety of techniques for intra- operative assessment and/orvisualization of the procedure, which may include: intra-operativeprobing, radiography (e.g., C-arm, flat plate), and endoscopy. It iscontemplated that the inventive embodiments described are not limited bythe various techniques that may be employed by the surgeon.

Treatment apparatuses, fixation apparatuses, and their delivery toolsand related methods in accordance with the present inventions may alsopull the tissues together that surround the aperture or defect, theinner surface, and the outer surface of the annulus to help close orotherwise repair the aperture, increase the integrity of the repair, andpromote healing.

In addition, the surgical approach to the intervertebral disc throughoutthe Figures and descriptions depict a common approach, with relatedstructures, to a lumbar discectomy; although, it is possible thatsurgeons may prefer alternative approaches to the intervertebral discfor various applications (for example, different intervertebraldisclevels such as the cervical or thoracic region, or for nucleusaugmentation), which may include, but are not limited to:posterior-lateral, anterior, anterior-lateral, transforaminal,extra-foraminal, extra-pedicular, axial (i.e., through the vertebralbodies), retroperitoneal, trans psoas (through the Psoas muscle), andcontralateral. The approach to the intervertebral disc space should notbe interpreted to limit the use of the inventions for the repair orreconstruction of a defect, aperture, weakened or thin portion of theannulus, as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate illustrative embodiments of theinvention and, together with the description, serve to explain theprinciples of the invention.

FIG. 1 illustrates an exemplary embodiment of a primary closure of anopening in the disc annulus in accordance with aspects of the presentinventions.

FIGS. 2A-2B illustrate an exemplary embodiment of a primary closure witha stent in accordance with aspects of the present inventions.

FIGS. 3A-3B illustrate an exemplary embodiment of an annulus stentemploying secondary barbed fixation apparatus in accordance with aspectsof the present inventions.

FIG. 4A illustrates an exemplary herniated disc in perspective view, andFIG. 4B illustrates the same disc after discectomy.

FIGS. 5A-5G illustrate an exemplary embodiment of an introduced andexpanded annulus stent/patch being fixated and the aperturereapproximated in accordance with aspects of the present inventions.

FIG. 6 illustrates an exemplary use of an embodiment of a fillermaterial within the aperture during placement of a patch/stent tetheredby a cinch line in accordance with aspects of the present inventions.

FIGS. 7A-7C illustrate exemplary embodiments of fixation apparatuses inaccordance with aspects of the present inventions having fixation tissueanchors.

FIGS. 8A-8C illustrate additional exemplary embodiments of fixationapparatuses in accordance with aspects of the present inventions havingfixation anchors.

FIG. 9 illustrates exemplary embodiments of a fixation apparatus inaccordance with aspects of the present inventions in a deliveredconfiguration that may result from the use of a single, or multiple,devices to deliver multiple barbs, tissue anchor, or T-anchorssequentially or simultaneously.

FIGS. 10A-10B illustrate exemplary embodiments of a fixation deliveryapparatus and fixation apparatus in accordance with aspects of thepresent inventions.

FIGS. 11A-11D illustrate exemplary embodiments of a fixation deliveryapparatus configured to simultaneously deliver two tissue anchors of afixation apparatus and the use of multiple fixation apparatuses togetherin repair of an intervertebral disc in accordance with aspects of thepresent inventions.

FIG. 12 illustrates exemplary embodiments of a fixation apparatus andfixation delivery apparatus in accordance with aspects of the presentinventions.

FIG. 13 illustrates exemplary embodiments of a transverse view of theplacement of a fixation element through a treatment device and theannular wall in accordance with aspects of the present inventions.

FIG. 14 illustrates exemplary embodiments of a transverse view of afixation element delivery device after affixing a fixation elementdelivered in FIG. 13 and partial removal of the fixation elementdelivery device in accordance with aspects of the present inventions.

FIG. 15 illustrates exemplary embodiments of a transverse view of thefixation element after removal of the fixation element delivery tool inaccordance with aspects of the present inventions.

FIG. 16 illustrates exemplary embodiments of a transverse view of anadditional fixation element locked in place on the opposite side of thetreatment device in accordance with aspects of the present inventions.

FIG. 17 illustrates exemplary embodiments of a sagittal view of theplacement of a fixation element delivery tool through a treatment deviceand the annular wall in accordance with aspects of the presentinventions.

FIG. 18 illustrates exemplary embodiments of a sagittal view of theplacement of an additional fixation element through a treatment deviceand the annular wall in accordance with aspects of the presentinventions.

FIG. 19 illustrates a saggital view of an-exemplary embodiments afterthe removal of the fixation element delivery tool in accordance withaspects of the present inventions.

FIG. 20 illustrates a view of an exemplary embodiment of a fixationdelivery apparatus pre-deployment in cross-section in accordance withaspects of the present inventions.

FIG. 21 illustrates a detailed view of the distal end of an exemplaryembodiment of an anchor band (fixation element) delivery tool incross-section in accordance with aspects of the present inventions.

FIG. 22 illustrates a detailed view of exemplary embodiments of a slidebody and cannula anchor of an exemplary fixation element delivery toolin cross-section in accordance with aspects of the present inventions.

FIG. 23 illustrates a detailed view of exemplary embodiments of ananchor band delivery tool in cross-section during a deployment cycle inaccordance with aspects of the present inventions.

FIG. 24 illustrates a detailed view of exemplary embodiments of thedistal end of an anchor band delivery tool depicted in FIG. 23.

FIG. 25 illustrates a detailed view of exemplary embodiments of a slidebody and cannula anchor of an exemplary fixation element delivery toolin cross-section during a deployment cycle in accordance with aspects ofthe present inventions.

FIG. 26 illustrates a detailed view of exemplary embodiments of a sutureretention block and blade assembly of an anchor band delivery tool.

FIG. 27 illustrates a detailed view of exemplary embodiments of ananchor band delivery tool in cross-section during the cutting of asuture tether and release of an anchor band in accordance with aspectsof the present inventions.

FIG. 28 illustrates a detailed view of exemplary embodiments of thedistal end of an anchor band delivery tool during release of the anchorband in accordance with aspects of the present inventions.

FIG. 29 illustrates a detailed view of exemplary embodiments of a sutureretention block and blade assembly of an anchor band delivery toolduring the cutting of the tether in accordance with aspects of thepresent inventions.

FIGS. 30A-30C illustrate a detailed view of exemplary embodiments of ananchor band or anchor band delivery tool for providing perceptiblefeedback in accordance with aspects of the present inventions.

FIGS. 31A-31B illustrate alternative illustrative mechanisms of drawingtogether locking elements/anchors in accordance with aspects of thepresent inventions.

FIGS. 32A-32B illustrate alternative illustrative attachment mechanismswhere a pledget element that-initially resides on outer annular surface.

FIGS. 33A-33D illustrate a fixation delivery apparatus and fixationapparatus in accordance with aspects of the present inventions.

FIGS. 34A-34C illustrate exemplary embodiments of a patch-like deliverytool in accordance with aspects of the present inventions.

FIGS. 35A-35B illustrate exemplary embodiments of a treatment deliverytool in accordance with aspects of the present inventions.

FIGS. 36A-36B illustrate exemplary embodiments of a patch delivery toolin accordance with aspects of the present inventions.

FIG. 37 illustrate exemplary embodiments of a device delivery tool inaccordance with aspects of the present inventions.

FIGS. 38A-38C illustrate exemplary embodiments of a patch and a patchdelivery tool in accordance with aspects of the present inventions.

FIGS. 39A-39E illustrate exemplary embodiments of a treatment device anda treatment delivery tool in accordance with aspects of the presentinventions.

FIGS. 40A-40E illustrate exemplary embodiments of a patch and a patchdelivery tool in accordance with aspects of the present inventions.

FIGS. 41A-41D illustrate exemplary embodiments of a patch and a patchdelivery tool in accordance with aspects of the present inventions.

FIGS. 42A-42D illustrate exemplary embodiments of a patch and a patchdelivery tool in accordance with aspects of the present inventions.

FIGS. 43A-43E illustrate an exemplary method for treatment of an annulususing embodiments of a treatment device and delivery tool, a fixationapparatus, and a fixation delivery apparatus in accordance with aspectsof the present inventions.

FIGS. 44A-44E illustrate an exemplary method for treatment of an annulususing embodiments of a patch-like device and a delivery tool, a fixationapparatus, and a fixation delivery apparatus in accordance with aspectsof the present inventions.

FIGS. 45A-45F illustrate an exemplary method for treatment of an annulususing embodiments of a treatment device and delivery tool, a fixationapparatus, and a fixation delivery apparatus in accordance with aspectsof the present inventions.

FIGS. 46A-46F illustrate an exemplary method for treatment of an annulususing embodiments of a patch, a patch delivery tool, a fixationapparatus, and a fixation delivery apparatus in accordance with aspectsof the present inventions.

All Figures are illustrated for ease of explanation of the basicteachings of the present inventions only; the extensions of the Figureswith respect to number, position, relationship and dimensions of theparts to form the preferred embodiment will be explained or will beunderstood within the skill of the art after the following descriptionhas been read and understood. Further, the exact dimensions anddimensional proportions to conform to specific force, weight, strength,and similar requirements will likewise be within the skill of the artafter the following description has been read and understood.

Where used in various Figures of the drawings, the same numerals maydesignate the same or similar parts. Furthermore, when the terms “top,”“bottom,” “right,” “left,” “forward,” “rear,” “first,” “second,”“inside,” “outside,” and similar terms are used the terms should beunderstood to reference only the structure shown in the drawings andutilized only to facilitate describing the illustrated embodiments.Similarly, when the terms “proximal,” “distal,” and similar positionalterms are used, the terms should be understood to reference thestructures shown in the drawings as they will typically be utilized by aphysician or other user who is treating or examining a patient with anapparatus in accordance with the present inventions.

DETAILED DESCRIPTION

All patents referred to or cited herein are incorporated by reference intheir entirety to the extent they are not inconsistent with the explicitteachings of this specification, including; U.S. Pat. No. 5,108,438(Stone), U.S. Pat. No. 5,258,043 (Stone), U.S. Pat. No. 4,904,260 (Rayet al.), U.S. Pat. No. 5,964,807 (Gan et al.), U.S. Pat. No. 5,849,331(Ducheyne et al.), U.S. Pat. No. 5,122,154 (Rhodes), U.S. Pat. No.5,204,106 (Schepers at al.), U.S. Pat. No. 5,888,220 (Felt et al.), U.S.Pat. No. 5,376,120 (Sarver et al.) and U.S. Pat. No. 5,976,186 (Bao etal.).

The figures generally illustrate fixation delivery apparatus 400,fixation apparatus 100, patches 600, and patch insertion tools 500including aspects of the present inventions. The particular exemplaryembodiments of the fixation delivery apparatus 400, fixation apparatus100 and patches 600 as illustrated in the figures have been chosen forease of explanation and understanding of various aspects of the presentinventions. These illustrated embodiments are not meant to limit thescope of coverage but instead to assist in understanding the context ofthe language used in this specification and the appended claims.Accordingly, variations of fixation delivery apparatus 400, fixationapparatus 100, patch 600, and patch delivery apparatus 500 for use inannulus repair may differ from the illustrated embodiments and may beencompassed by the appended claims.

Reference will now be made in detail to selected illustrativeembodiments of the inventions, with occasional reference to theaccompanying drawings. When possible, although not intending to belimiting, many of the same reference numbers may be used throughout thedrawings to refer to the same or similar elements.

In the surgical repair of an annulus 42 having an aperture 44, as shownin FIG. 1 and as described in related commonly-assigned U.S. Pat. No.6,592,625 to Cauthen, a damaged annulus 42 is repaired by use ofsurgical fixation apparatus 100. One or more surgical sutures 100 areplaced at about equal distances along the sides of a pathologic aperture44 in the annulus 42. Reapproximation or closure of the aperture 44 isaccomplished by tying the sutures 100 so that the sides of the aperture44 are drawn together. The reapproximation or closure of the aperture 44enhances the natural healing and subsequent reconstruction by thenatural tissue (e.g., fibroblasts) crossing the now surgically narrowedgap in the annulus 42. Preferably, the surgical sutures 100 arebiodegradable, but permanent non-biodegradable may be utilized. In allembodiments where biodegradable materials are indicated, suitablebiodegradable materials may include, but are not limited to,biodegradable polyglycolic acid, swine submucosal intestine, collagen,silk or polylactic acid. Other suitable suturing (and band) materialsinclude, e.g., polymeric materials such as polyethylene teraphthalate(PET), polyester (e.g., Dacron™), polypropylene, polyethylene,polycarbonate urethane and/or metallic material include, e.g., titanium,nickel titanium alloy, stainless steel, surgical steels or anycombinations thereof.

Additionally, to repair a weakened or thinned wall of a disc annulus 42,a surgical incision or dissection can be made along the weakened orthinned region of the annulus 42 and one or more surgical sutures 100can be placed at about equal distances laterally from the incision.Reapproximation or closure of the incision is accomplished by tying thesutures 100 so that the sides of the incision are drawn together. Thereapproximation or closure of the incision/dissection enhances thenatural healing and subsequent reconstruction by the natural tissuecrossing the now surgically narrowed gap in the annulus 42. Preferably,the surgical sutures 100 are biodegradable, but permanentnon-biodegradable materials may be utilized.

Where necessary or desirable, the method can be augmented by placing apatch 600 in and across the aperture 44. The patch 600 acts as a bridgein and across the aperture 44, providing a platform for traverse offibroblasts or other normal cells of repair existing in and around thevarious layers of the disc annulus 42, prior to closure of the aperture44. FIGS. 2A-B, for example, show a biocompatible device employed as anannulus stent 600, being placed in and across the aperture 44. Theannulus stent 600 may act as a bridge in and/or across the aperture 44,providing a platform for a traverse of fibroblasts or other normal cellsof repair existing in and around the various layers of the disc annulus42, prior to closure of the aperture 44. In some embodiments the device,a stent or patch can act as a scaffold to assist in tissue growth thathealingly scars the annulus.

In an illustrative embodiment, the annulus stent 600 is a solid unit,formed from one or more of the flexible resilient biocompatible orbioresorbable materials well know in the art. The selection ofappropriate stent materials may be partially predicated on specificstent construction and the relative properties of the material suchthat, after fixed placement of the stent, the repair may act to enhancethe healing process at the aperture by relatively stabilizing the tissueand reducing movement of the tissue surrounding the aperture.

For example, the annulus stent 600 may be made from:

A porous matrix or mesh of biocompatible and bioresorbable fibers actingas a scaffold to regenerate disc tissue and replace annulus fibrosus asdisclosed in, for example, U.S. Pat. No. 5,108,438 (Stone) and U.S. Pat.No. 5,258,043 (Stone), a strong network of inert fibers intermingledwith a bioresorbable (or bioabsorbable) material which attracts tissueingrowth as disclosed in, for example, U.S. Pat. No, 4,904,260 (Ray etal.); a biodegradable substrate as disclosed in, for example, U.S. Pat.No. 5,964,807 (Gan at al.); or an expandable polytetrafluoroethylene(ePTFE), as used for conventional vascular grafts, such as those sold byW. L. Gore and Associates, Inc. under the trademarks GORETEX andPRECLUDE, or by Impra, Inc. under the trademark IMPRA.

Furthermore, the annulus stent 600, may contain hygroscopic material fora controlled limited expansion of the annulus stent 600 to fill theevacuated disc space cavity.

Additionally, the annulus stent 600 may comprise materials to facilitateregeneration of disc tissue, such as bioactive silica-based materialsthat assist in regeneration of disc tissue as disclosed in U.S. Pat. No.5,849,331 (Ducheyne, et al.), or other tissue growth factors well knownin the art.

It is anticipated that fibroblasts will engage, for example, fibers orfabric of the patch 600 forming a strong wall duplicating the currentlyexisting condition of healing seen in the normal reparative process.Moreover, many of the materials disclosed and described above representembodiments where the device actively promotes the healing process. Itis also possible that the selection of alternative materials for thetreatment devices or treatments may modulate the role in the healingprocess, and thus promote or prevent healing as may be required. It isalso contemplated that these modulating factors could be applied tomaterial substrates of the device as a coating, or similar covering, toevoke a different tissue response than the substrate without thecoating.

Materials of the patch 600 could include a metallic material (e.g., NiTialloy, Stainless steel, Titanium), or a polymeric material (e.g.,polypropylene, polyethylene, polyurethane, polycarbonate urethane,Polyetheretherketone (PEEK), polyester, PET, poly olefin copolymer,polypropylene, polyethylene), or a biodegradable or bioresorbablematerial (e.g., collagen, cellulose, silk, polysaccharide, polyglycolicacid (PGA), a polylevolactic acid (PPLA), a polydioxanone (PDA) or forexample a racemic polylactic acid (PDLLA), or a combination of thesematerials.

FIG. 3A shows an alternative fixation strategy where a pair of barbs 134and 136 are plunged into the annulus fibrosus from the exterior of theannulus while the device 600 is retained in the sub-annular space bymeans of a tether 142. Although there are a wide variety of fixationdevices that could be used in this particular example, a tether 142 maybe knotted 145 with the band 144 holding the barbs 134 and 136 togetherto fix the device in the sub-annular space. The knot is shown in anuncinched position to clarify the relationship between the tether 142and the bands 144. Using this approach, the device can be maintained ina subannular position by the barbed bands 134, 136 while the tether knot145 is cinched, advantageously simultaneously reapproximating theannulus to close the aperture while drawing the device into sealing,bridging engagement with the subannular wall of the annulus fibrosus.

FIG. 3B shows an alternative fixation strategy where the barbs 148 and150 are sufficiently long that they can pierce the body of the device600 and extend all the way through the annulus fibrosus into the device600. In this configuration, the band 144 connecting the barbs 148 and150 may be tightened to gently restrain and position the device 600 inthe sub-annular space, or tightened with greater force to reapproximatethe aperture or rent.

It is understood that there can be a variety of device designs ofpatches, stents, meshes, barriers, scaffolds sealers, occluders orotherwise treatment devices 600 for repair of annular defects and theymay, in at least some of the embodiments, be configured to accomplishthe expansion of a device from a first configuration, to a secondconfiguration to occupy at least a portion of the sub-annular space andreduce re-extrusion of the nucleus, or otherwise facilitate maintainingother intradiscal materials within the disc space. These devices can beconstructed of single components or multiple components, with a varietyof different materials, whether synthetic, naturally occurring,recombinant (genetically engineered) to achieve various objectives inthe delivery, deployment and fixation of a device to repair orreconstruct the annulus. The following device concepts are furtherdiscussed for additional embodiments of a device and/or system for therepair of an intervertebral disc annulus. The following descriptionswill illustratively depict and describe methods, devices, and tools todeliver a treatment to an intervertebral disc after a lumbar discectomyprocedure; although, it is anticipated that these methods, devices, andtools may be similarly used in a variety of applications. As an example,the embodiments described herein may also advantageously maintain othermaterials within the disc space rather than natural disc tissue(nucleus, annulus, cartilage, etc.), such as implants and materials thatmay be used to replace and/or augment the nucleus pulposus or otherparts of the disc's tissues. These procedures may be performed to treat,for example, degenerative disc disease. Whether these materials areintended to replace the natural functioning of the nucleus pulposus(i.e., implantable prosthetics or injectable, in-situ curable polymerprotein, or the like) or provide a fusion between vertebral bodies(i.e., implantable bony or synthetic prosthetics with materials tofacilitate fusion, such as growth factors like bone morphogenicproteins) one skilled in the art would realize that variations to theembodiments described herein may be employed to better addresscharacteristic differences in the various materials and/or implants thatcould be placed within the disc space, and that these variations wouldbe within the scope of the invention.

It is also important to note that the boundary in the intervertebraldisc space between the annulus fibrosus and the nucleus pulposus asdepicted herein may be demarked or otherwise highlighted; however, it isimportant to recognize that these tissues are not as precisely demarkedin human tissues, and may be even less so as the patient ages or evincesdegeneration of the intervertebral disc. This demarcation may beespecially difficult to discern during an operative procedure, using forexample; available surgical tools (i.e., probes), fluoroscopic guidance(x-ray), or visual (endoscope) guidance. However, in general, the layersof the annulus have more structural integrity (and strength) than thenucleus, and this integrity varies from the outer most layers of theannulus typically being of higher structural integrity than the innermost layers of the annulus.

As depicted in FIG. 4A, a herniated disc occurs when disc nucleusmaterial protrudes or emerges from the intervertebral disc. Herniateddisc material can impinge on nerve tissue, causing pain. A discectomyattempts to relieve pressure on the nerve tissue through surgicalremoval of disc material, the result usually being an aperture and adefect in the disc annulus wall, and frequently a void in the disc spacewhere disc nucleus fragment was removed, as shown in FIG. 4B. FIG. 4Btypifies a disc after the discectomy procedure has been performed, as domost of the drawings and descriptions contained herein; although, oneskilled in the art would understand that these inventions may be used toenable other disc repair procedures such as nucleus replacement,interbody fusion, and posterior/anterior dynamic stabilization. Inaddition, it should be understood that in order to perform a discectomyprocedure, there are a variety of instruments and tools readilyavailable to the surgeon during spine surgery, or other surgicalprocedures, to obtain the outcome as shown in FIG. 4, or other outcomesintended by the surgeon and the surgical procedure. These tools andinstruments may be used to: incise, resect, dissect, remove, manipulate,elevate, retract, probe, cut, curette, measure or otherwise effect asurgical outcome. Tools and instruments that may be used to performthese functions may include: scalpels, Cobb elevators, Kerrison punch,various elevators (straight, angled, for example a Penfield), nerveprobe hook, nerve retractor, curettes (angled, straight, ringed),rongeurs (straight or angulated, for example a Peapod), forceps, needleholders, nerve root retractors, scissors. This list is illustrative, butis not intended to be exhaustive or interpreted as limiting. It isanticipated that some of these tools and/or instruments could be usedbefore, during, or after the use of the inventive methods, devices andtools described herein in order to access, probe (e.g., Penfieldelevator), prepare (e.g., angled or ringed curette, rongeur, forceps),and/or generally assess (e.g., angled probe) a treatment site orfacilitate the manipulation (e.g., forceps, needle holder), introduction(e.g., forceps, needle holder, angled probe), or deployment (e.g.,forceps, needle holder, angled probe) of the treatment device and/or itscomponents.

There are a variety of ways to affix a treatment device to a wall of theannulus as well as reparatively fix or mend an annular defect inaddition to those discussed herein above. The following exemplaryembodiments are introduced here to provide inventive illustrations ofthe types of techniques that can be employed to reduce the time andskill required to repair an annulus, versus suturing and tying a knot.

An illustrative example of affixing a device 600 to a wall of theannulus 712 is further illustrated by FIGS. 5A-5G. As discussedhereinabove, with reference to FIGS. 3A-3B, a patch 600 is placed with adelivery tool 704, through the inner lumen of a guidetube, into the discspace and then expanded. This step can also include a patch 600 foldedand passed through a guide tube surrounded by and held by a deliverytool 704. Also shown is an anchor band or staple 709 and an anchor banddelivery device 708. Within the guide tube, or within the delivery tool,there is a suture line or cinch line 710 that is attached to the centerof the patch 600. This can be seen in FIG. 5A with the guide tuberemoved. The guide tube may be retracted after the patch 600 has beenexpanded and deployed. Next, as shown in FIGS. 5A-5G, an anchor banddelivery tool 708 is used to deliver one or more “bands” 709 into and onthe outer surface of the annulus. These are intended to be anchored intoand/or through the wall of the annulus with barb shapes that do notallow for the barbs to be pulled back through the annulus. The tissueanchor bands or fixation apparatuses, resemble a construction of a“staple”. The bands could actually be constructed by connecting twobarbed elements with, for example, a suture between the two barbedelements.

Fixation apparatuses 100 comprising barbs and connection bands betweenbarbs could be constructed of the same material or of differentmaterials. For example, the barbed part 709″ of the anchor band could bea biodegradable/bioabsorbable material (such as, for example, collagen,cellulose, polysaccharides, carbohydrates, polyglycolic acid,polylevolactic acid, polydioxanone, racemic polylactic acid) or could beconstructed of a metallic or polymeric biocompatible material (e.g.,titanium, NiTi alloy, stainless steel, platinum, gold, polyurethane,polycarbonate urethane, polyimide, polyamide, polypropylene,polyethylene, polypropylene, polyester, PET, PEEK). The anchors couldalso be constructed of a combination of these materials. In addition,the band 709′ that connects these barbs could be constructed ofmaterials that are similar to the barbs, or different materials. Forexample, the connection band could be a biodegradable/bioabsorbablesuture, such as Vicryl, or a biocompatible material such aspolypropylene, polyethylene, silk, stainless steel, PET. In addition, itis possible that these elements are constructed from multiple materialsto accomplish the objective of anchoring into the annulus or other disctissue in proximity of the annulus and providing for a fixation site todraw the tissues together.

FIGS. 5A to 5G show the placement of a patch 600 with a patch deliverytool 704 and the placement of anchor bands 709 with delivery tool 708.The figures schematically show the placement of the tissue anchor bands709 into the wall of the annulus 712 and the retraction of the anchorband delivery device 708 and the patch delivery tool 704. FIG. 5Ddepicts a representative anchor band 709, having a pair of stainlesssteel barbs 709″ connected by a suture 709′. FIG. 5E shows the patch600, anchor bands 709, and cinch line or suture 710 with the deliverytools removed, prior to drawing the patch and the tissues of the annulustogether. In this embodiment there is a pre-fabricated slip knot 714 onthe cinch line, although other locking elements or knots are possible.Suture loops can connect to the barbs directly, as in FIG. 5, or loop tosurgical staples, or placed directly into the annulus. The presence of apre-fabricated knot on the cinch line makes the process of repairingquicker since there is no need to tie a knot. It also facilitatesdrawing towards one another the tissues adjacent the aperture and thepatch. The use of the cinch line and a pre-fabricated knot can be placedby, for example, an external tube such as a knot pusher. FIG. 5E issimilar to FIG. 3 described hereinabove prior to “tying” the knot 714.FIG. 5F shows the drawing of the patch and the annular tissues togetherby pulling on the tether in the direction “A” indicated by the arrow. Inthis case, the knot pusher has been removed from the cinch line 710. Thesuture 710 is drawn proximally to draw the patch 600 into engagementwith the inner wall of the annulus to seal the aperture from within, aswell as it may draw the tissues of the annulus together so as to, atleast partially, reapproximate the annular aperture. FIG. 5G show thecinch line suture 710 tied and drawing the annular tissues together,after the excess suture line has been cut. It is also apparent from thisdevice, fixation and delivery system that the outer surfaces of theaperture may be drawn together for re-approximation.

The cinching of the tissue anchor bands and the patch also allows fortaking-up the slack that allows for the accommodation of varying discsizes. For example, the thickness of the annular wall surrounding theaperture can vary from 1 mm up to 10 mm. Therefore, if the tissue anchorbands have a set length, a design with a cinch line accommodatesdifferent dimensions of the thickness of the wall of the annulus bydrawing the “slack” of the bands together within the aperture.

Although it has been described here as patch placement that involves twolateral anchor bands 709 with a suture to draw the patch, bands andtissues together, one or two or more bands could be used and two bandsis only an example. Furthermore, the tissue anchor bands were placedwith the barbs in a superior-inferior fashion. One skilled in the artwould recognize that these could be placed at different locationssurrounding the aperture, vertebral bodies or into the Sharpey's fibers

Although the patch 600 depicted in the example above does not have barbsattached to the patch, it is also possible to have barbs attached tofurther promote the affixation of the patch to the wall of the annulus.

Finally, although the drawings depict an aperture that lends itself tore-approximating the tissues, it is conceivable that some apertures,whether natural or surgically made, may be relatively large andtherefore might require the placement of additional material within theaperture to act as a scaffold for tissue ingrowth, between the patch onthe inner wall of the annulus and the anchor bands located on the outerwall.

An example of material to fill the annular aperture might includeautograft para-spinal fascial tissue, xenograft, allograft, or othernatural collagenous materials. The filler material could also be of abiocompatible material such as a Dacron (polyester, or PET),polypropylene, polyethylene, silk, or other scaffolding-type material.FIG. 6 shows the illustrative filling of an aperture with implantmaterial 716 prior to cinching the suture 710.

As an alternative embodiment of the present invention, the anchor bands709 as described previously (anchor bands into annulus) could besufficiently long enough to pass through the annulus and then throughthe patch. The barbs in this embodiment have an engaging involvementwith the patch. This concept was previously discussed hereinabove inconnection with FIG. 3.

As an alternative embodiment of the present invention, it is conceivablethat some annular defects may be readily repaired without the use of apatch-like device and could advantageously be mended, partially orwholly, through tissue approximation. Exemplary of a reapproximationwithout a patch-like device could be performed with the repair apparatusof FIG. 5G wherein cinch line 710 is employed to draw together bands 709without patch 600 present. It is also possible, given alternativepresentations of annular defects, that a re-approximation could also beperformed with the repair of FIG. 6 wherein cinch-line 710 is employedto draw together bands 709 with filler material 716 and without patch600 present. In this alternative embodiment, fill material 716 may bedirected affixed, or otherwise secured, to cinch-line 716 and/or one ormore bands 709 so as to retain filler material 716 in proximity of theannular defect.

Although the bands shown in FIGS. 5A to 5G take the form of a “barb”,they could as easily take a form of a simple T-barb, or a C-type elementwherein the object is to have irrevocable engagement with the patchdevice 600 or tissue after the penetration through the patch or tissue.A T-type attachment, when aligned longitudinally with the suture, passesthrough the patch. The T-section may then rotate so as to prevent thesuture anchor from being pulled back through the patch. In anotherembodiment a “C” retainer made of a superelastic material may beattached to the end of the suture band. The C-retainer is loaded into aneedle wherein it is held straight. The needle is used to pass theC-retainer and suture through the patch and deploy the retainer in asecond configuration in the shape of a “C”. In general those skilled inthe art can realize alternative anchoring forms for patch deviceaffixation or reparative treatment that may take a variety ofconfigurations including barbs, t-anchors, staples, anchors,c-retainers, open helical screws, screens, darts, tines, etc.

It is also foreseen within the scope of the invention that there may bepatch-like designs 600 which will accommodate the placement andsecurement of the anchor to the fabric that covers the frame of thepatch. For example, a frame for a patch that is made out of metal suchas Nitinol can provide for “windows”. The device, covered with a meshfabric, for example silicone or Dacron, might allow for the anchoringbarbs to be passed through the “windows” in the frame of the patch. Inthis case, the barb may be secured to the patch in the fabric coveringthe frame.

Alternatively, the patch could be secured by passing barbs that engagethe lattice of the patch frame. These embodiments of the inventionillustrate designs in which the barbs engage with the vertical,horizontal or criss-crossed structures/members of the frame. In thiscase, the barbs would pass through the mesh or lattice of the frame andthey would be unable to pass back out of the frame structure.

Although this discussion refers to “anchor bands” that are shown to betwo anchors connected by a suture, it is also contemplated that singlebarbs with sutures could be placed and the sutures' ends, at the outersurface of the annulus, could be tied after placement through the patch.It is also possible that these “single anchors” could be retained by asuture “pledget” on the outer wall of the annulus to better hold theouter surface, or could include a suture (or band) locking device.

One objective in the designs discussed hereinabove is to provide a wayto “pull up the slack” in a system to adjust the length of sutures oranchor bands. According to another embodiment of the inventions, a“Lasso Cinch Knot” was developed as a means to draw the tissue anchorbands together with a suture cinch line that is incorporated into thepatch design.

Alternative exemplary locking mechanisms are shown in FIGS. 7A to 7C,although in this case the engagement of the locking element 914′ takespart on the anchor 916. Pulling tether 910 in the direction of arrow Bwill tighten and lockingly hold in tension to aid in securement andtissue approximation. The adjustable length of band between the twoanchors allows slack to be taken up between the anchors 916. Two T-typeanchors are illustratively shown in this example, but multiple tissueanchors of differing configurations could be used. The locking featurescan be included on the band, as depicted here, and allow forsubstantially one-way locking engagement with the anchor members. Thisadjustability advantageously promotes for the accommodation of varyingthickness of the annulus from patient to patient and pathologicalpresentation. The suture/band slack in this embodiment may be taken upto partially or wholly close the defect in the annulus and/or to shortenthe band between anchors for a secondary cinching of multiple tensionedsuture bands as described herein.

FIGS. 8A to 8C show alternative embodiments for tightening “anchoringbarbs” with different configurations of bands and cinch lines. In oneexample, each independent barb has a looped, elongate, flexible element,such as a suture, attached to it. Through each of these loops is passeda cinch line, which comprises a knot. After placement of the barbswithin and/or through the annulus, and possibly through the patch, thecinch line draws the loops of the barbs together. The advantage of thisembodiment is that it allows for the independent placement of multiplebarbs and the ability to draw all of them together.

Although cinch lines have been described as using a knot to “lock” thelength of the suture, other mechanisms could also lock the length, forexample, those shown in FIG. 7. The locking of the suture length isaccomplished through a mechanical element located on the barb whichengages with three dimensional elements attached to the suture linewhich mechanically press fit through the engagement element on the barb,thus locking the length of the suture line into place.

Although the embodiments of FIGS. 7 and FIGS. 8 depict the use of asingle locking mechanism (e.g., knot on cinch line), it is conceivablethat various designs could use more than one locking element to achievethe re-approximation and drawing towards one another tissue adjacent anannular aperture or defect.

Similarly, an alternative embodiment to cause tension within the deviceand draw the tissues together after placement of the anchor bands mightinclude an elastic band or band with a spring which one end can beattached to the anchor bands and the other end attached to the patch.Alternatively, the anchor bands might, in and of themselves may be madeof an elastic band between the barbs, or may contain a spring elementbetween the barbs. Again, it is contemplated that the elastic orresilient element could be made from a wide variety of metals,polymeric, or biodegradable/bioabsorbable material.

As previously mentioned, the present invention also encompasses deliverydevices or tools. The delivery devices of the present invention areconfigured to deliver at least one, or a portion thereof, reparativedevice within, through, onto, proximate or into, the annulus or othersurface or tissue surrounding the intervertebral disc. The deliverytools (or devices) will typically comprise devices or shafts havingproximal and distal ends. As referred to herein, the proximal portion ofa device or tool or component will generally refer to the portion of thedevice/tool/component that is located furthest away from the patient(and closest to the surgeon); whereas, the distal portion will generallyrefer to the portion that is within (in use), or closest to the patient(and therefore furthest away from the surgeon). Although some of thedevice descriptions may refer to some fixation element embodiments asbeing “fixation” or “anchor/anchor band/barb”, this is done for clarityreasons and should not be misconstrued to suggest that the device is notcapable of also performing a treatment and/or a repair.

In addition, the following descriptions of delivery devices/tools aregenerally intended to be single-use and disposable; however, it is clearthat these tools could as easily be constructed to be partially, orwholly, re-usable and re-sterilizable.

Illustrative delivery devices as depicted in FIGS. 10-12 may beconfigured to accommodate and deploy at least one anchor device, such asa barb or T-anchor with one or more associated bands. Advantageously,the distal end of the delivery device will comprise a hollow needle orcannula 711, having a circular, elliptical, triangular, hexagonal orother inner cross-sectional area, suitable to accommodate thecross-sectional shape of the fixation device within. The distal point ofthe cannula 711 is advantageously sharpened, as a needle, to accommodateinsertion into tissue. The cannula 711 is advantageously cut obliquelyas shown in FIG. 12 to form a sharp leading surface or point for ease ofinsertion. The cannula 711 may contain a cut or groove 718 along itsside to accommodate one or more anchors 709″ with bands 709′ as shown(or barbs, not shown), e.g., in FIGS. 10B or 12. In one embodiment, theat least one fixation device (including band and barb or T-anchor), orportion thereof, is disposed within the cannula 711 as shown in FIGS. 10a, 10 b, and/or 12. Alternatively, the T-anchor assembly 709 (or barb,not shown), or other fixation device may be hollow and disposed in amanner surrounding, and mounted on the device of the delivery device.

The delivery device 708 may also advantageously contain within it anejection rod 715. The proximal end of the ejection rod 715 may containan end portion 713 to function as a stopper, e.g., having a diameterlarger than the remaining portion of the rod, such as is shown in FIG.10A or 12. The diameter of the remaining portion of the ejection rod 715may be small enough for insertion within the shaft of the device 708.Upon insertion of the cannula 711 into the location of choice, theejection rod is pushed to deliver the fixation device. The deliverydevice is then removed.

Advantageously, the ejection rod 715 and delivery device may beconfigured to deliver multiple fixation devices, sequentially orsimultaneously. Thus, if multiple fixation devices are contained withinthe device, the ejection rod 715 and delivery device may be configuredsuch that the rod 715 be pushed a first distance, sufficient to delivera first anchor of a fixation device. The delivery device is then removedfrom the first insertion point and inserted into a second insertionpoint, where the ejection rod is then pushed a second distance fordelivery of a second anchor of a fixation device, and so-on as desired.For simultaneous delivery of multiple fixation devices, multipledelivery devices may be arranged in parallel (or substantiallyparallel). The distance between (or among) the delivery devices may befixed or adjustable, as desired.

The distance the ejection rod 715 is pushed to define a first, second,and subsequent distances may be regulated by feel. Alternatively, thedistance can be regulated by the architecture of the device. Forexample, the shaft and ejection rod may be fitted with anotch-and-groove configuration, respectively. In such configuration, thenotch in the outer surface of the ejection rod may be aligned with agroove in the inner surface of the device. The length of the groovedefines a first distance. The ejection rod 715 would be then turned orrotated within the device, aligning the notch within the device to asecond groove defining a second distance, and so-on. In an alternativeembodiment, the ejection rod and tissue anchor portion of the fixationdevice (e.g., barb or T-anchor) may surround the shaft of the device, asa sleeve surrounds an arm. In such a configuration, the delivery toolwould comprise a solid shaft and the ejection rod and fixation devicewould be at least partially hollow and disposed over the distal portionof the delivery device. Pushing the ejection rod in a proximal to distaldirection would deploy the tissue anchor portion of the fixation device.

FIGS. 10A and 10B describe one embodiment of an anchor band deliverydevice 708 and fixation means. FIG. 10A shows a general drawing of adelivery device. FIG. 10B further depicts the distal end of the deliverydevice. As illustrated, anchor band delivery device 708 contains twopointed needles or cannulae 711. Each cannula 711 contains an anchoringT-type anchor 709″ (or barb) positioned within the distal end of thecannula 711. A band 709′ links the two tissue anchors 709″ (or barbs)together and a cinch knot 714 secures the anchors (or barbs). Cinch line710 is pulled to decrease the length of the band 709′ that attaches theanchors 709″.

Referring to FIG. 11A, anchor band delivery device 708 is inserted intothe annulus 712 sufficiently to engage the layers of the annulus 712,and preferably located at the inner wall of the annulus 712. The anchors709″ may be ejected from the delivery device by pressing the ejectionrod 715 in a fashion to expel the T-anchors 709″ (or barbs, not shown)from the device. For example, pressing on the proximal end of ejectionrod 715, as shown in FIG. 10A, drives the ejection rod 715 in a distaldirection, thus expelling the anchor from the device. FIG. 11B shows theanchors 709″ (or barbs) after being ejected. FIG. 11C shows a knotpusher 716, that can be attached to the delivery tool 708, or usedseparately, that can be used to tighten the knot 714 once the fixationdevice is secured into the annular tissue. FIG. 11C shows the placementof two anchor bands or fixation devices 709 (anchors and bands), afterthey have been delivered to the annulus and before the bands 709 havebeen tightened. The knot pushers 716 of both devices are still incontact with the knots and the delivery needles have been pulled back,away from the annulus. FIG. 11 D shows the final placement of the twoanchor bands or fixation apparatuses 709 after drawing together thetissues surrounding the aperture 717, the inner wall of the annulus 712,and/or the outer wall of the annulus; and, after tightening the knot andcutting excess suture material located on each anchor band. Althoughthis FIG. 11 shows the passage of two bands 709 superior and inferior tothe aperture and along the defect, these bands could as easily be placedin a multitude of locations to effect desired or equivalent outcomes,including and not to be limited to, a cruciate configuration.

In addition, as previously described, one could use barbs having amultitude of configurations. One could also configure delivery devicesto deliver one (as in FIG. 12), two (as in FIG. 10A), or more barbssimultaneously, and according to predetermined or variable distances orpatterns. The delivery devices may also be configured to eject one, two,or more barbs sequentially. Further, the barbs could be delivered by adelivery device that does not require a cannula to cover the barb. Insuch a configuration, the barb may be disposed on the tip or outside ofthe delivery device's shaft, and removed therefrom upon injection intothe desired location of the annulus or other tissue. Bands and knots maybe pre-tied to accommodate each configuration, as previously discussed.

For example, although FIGS. 10 and 11A-B depict a device that places afixation apparatus (e.g., two anchors 709″ banded together) with onedelivery device, one could accomplish an equivalent or other desiredresult with a single device that delivers multiple bands at the sametime, or conversely multiple delivery devices that deliver portions ofthe fixation apparatus.

FIG. 12 shows an alternative delivery device that delivers two or moreanchors (or barbs) from a single cannula 711. In this embodiment, afirst single tissue anchor 709″ may be ejected from the cannula 711 bypushing the ejection rod 715 a first distance sufficient to eject thefirst tissue anchor 709″, but insufficient to eject the second. Then thedelivery device is removed from the first site and passed into anotherannular location. The second anchor (or barb) 709″ connected to thefirst anchor or barb by band 709′, is ejected out of the cannula 711 bypushing the ejection rod 715 an additional distance sufficient to ejectthe second anchor 709″(or barb) into a second fixation point in theannulus.

Although much of this description has described placement of anchorsinto the annulus (or soft tissue) of the disc, one could perform tissueanchoring into other tissues surrounding the annular defect, includingthe bone, Sharpey fibers or surrounding ligaments. It is alsocontemplated that, given the delivery device construction, a bone drillor similar device may be necessary to facilitate the placement of thedelivery device through bony or similar tissue.

The band 709′ connecting the thus implanted anchors may advantageouslycontain a moveable knot 714 between the anchors. Suitable knots include,but are not limited to, the Roeder knot and its functional equivalents,and are advantageously, but not necessarily, pre-tied. After insertionof both anchors 709″, the band 709′ is advantageously tightened by handor by pushing on the knot with a knot-pusher or similar device. Althoughnot shown in FIG. 12, the knot pusher may be integral to the deliverydevice. After drawing together the tissues surrounding an annular defectthe excess suture line can be cut. It is also possible to use a cuttingdevice integral to the delivery device to cut the band after cinching.Although the device shown in FIG. 12 depicts two tissue anchors beingdelivered from a single device, multiple tissue anchors or barbs couldbe delivered from the same or a similar type of device. Additionally, adelivered configuration of fixation means may result from the use of asingle device to deliver multiple tissue anchors sequentially.

The shaft of the device may be of any convenient length, typically from,e.g., 1 inch to 10 inches. Materials of which to make the deliverydevice include, but are not limited to: metals, such as stainless steel,nickel, titanium alloy, and titanium; plastics, such as PTFE,polypropylene, PEEK, polyethylene, and polyurethane, acrylic,polycarbonate, engineering plastics; and/or composites.

Advantageously, the shaft of the device may have a cross-sectional shapesuitable to accommodate an ejection rod and at least one fixationelement, or portion thereof. In one embodiment, at least a portion ofthe shaft of the device may be hollow, having a circular, elliptical,triangular, trapezoidal or other suitable cross-sectional areasufficient to accommodate an ejection member.

The delivery device may also contain a handle or raised surfaceconfigured to accommodate the shape of surgeon's hands or fingers foreasier handling. Such raised or configured portion may be made of thesame or different material as the tube or shaft. Suitable materialsknown in the art include, among others, polymers, such as acrylicpolymers, polyurethane, polycarbonate, engineering plastics; and metals,such as stainless steel and titanium.

Many of the inventive embodiments disclosed herein relate to the use ofa patch stent, barrier, scaffold, membrane, mesh or similar reparativetreatment device for annular repair and/or reconstruction. In someclinical instances, the method of the invention may be accomplishedwithout the use of a patch-like device, however. For example, a patchmay be unnecessary to repair small apertures or apertures of certainshapes, or certain weakened or thin portion(s) of an annulus. Therefore,inventions herein also encompasses methods for repairing orreconstructing annular tissue that do not necessarily necessitate theuse of a patch, has exemplified in FIG. 11. Accordingly, an additionalembodiment of the invention also provides fixation devices that may beused to reapproximate, repair, reconstruct, reinforce, support, hold,retain or otherwise treat annular tissue. Such fixation devices andtheir delivery apparatuses, as described herein, may contain an anchorportion and a band portion. The tissue anchor portion serves to fix thefixation device in tissue proximate the disc. The band portion, attachedto the tissue anchor portion, serves to reparatively draw togetherannular tissue when tightened and secured. At least one fixation devicemay be placed into, or through, the wall of an annulus surrounding anaperture, weakened, delaminated, or thin portion of the annulus. Thedevice is then drawn in tension to pull together, wholly or partially,the surrounding annular tissue.

The band and the barbs may be separate elements or comprise onecontinuous element. Bands and barbs may be made of the same or differentmaterials.

The bands, or elongate members, may be string-like, made from suture orsimilar material, or of any construction or dimension that is amenableto the delivery and engagement of the fixation device. For example, theband may have a width greater than, in some embodiments far greaterthan, its thickness. The suture material may in some embodiments have awidth:height ratio of 1.25:1. In some embodiments, bands may beconstructed, wholly or partially, of a mesh tube. Moreover, differentsegments along the length of the band may have different dimensions andconstructions. For example, the band may be constructed of thinmaterial, such as nickel titanium alloy or stainless steel wire, closeto the anchor barbs, while the middle portion that spans the aperturemay comprise a much wider band made of optionally softer material, ormaterials conducive to tissue ingrowth and/or tissue regeneration.

FIGS. 7, 8, and 9 show examples of embodiments of the invention forrepair or reconstruction of the annulus that could be utilized withoutthe additional use of a patch-like device. For instance, in FIGS. 7A-7C,in lieu of (or optionally in addition to) a patch, two anchors are shownhaving passed into annular tissue 906. By drawing on band 910, theannular tissue 906 may be drawn together in tension, and may alsoreapproximate the tissue surrounding the annular aperture. FIG. 7C showsa single tissue anchor band being placed along an incision or tear inthe annulus.

The fixation devices 100 of the invention could be delivered as a pairof barbs attached by a single band, or each barb could be deliveredindividually. Alternatively, multiple barbs (anchors) may bepre-attached to a single or multiple bands for ease and speed ofdelivery. For example, FIG. 9 exemplifies a fixation device that hasmultiple anchors 916 (or barbs, not shown) connected together in aconfiguration similar to FIGS. 8B and 8C, with each anchor 916 beingdelivered individually into, or through the nucleus or annulus. Theanchors, if present, may be shown as in FIG. 9. By drawing on the cinchline, the tissues surrounding the aperture and/or the inner wall of theannulus and/or the outer wall of the annulus may be drawn together.Although a knot 914 is shown to affix the suture lines together, othermeans to lock, fasten clip, retain, or otherwise secure the suturestogether may also be used.

FIGS. 13-19 depict an illustrative method for the deployment of atreatment device into the intervertebral disc 200. As describedpreviously, there are a variety of applications, approaches, techniques,tools, and methods for accessing and performing spinal disc surgerywhich may be dependent on physician preferences and could be arbitrary.Therefore, the following description and depiction of the method shouldbe considered illustrative and not limiting. In the illustrativescenario which is used in the following descriptions, and the disc 200,which is comprised of the annulus fibrosus 202 and the nucleus pulposus204, is shown in a transverse cross-section in FIGS. 13-16 and asagittal cross-section in FIGS. 17 and 19. The disc 200, as describedabove, is disposed anatomically between caudal and cephalad vertebralbodies. The disc 200 may be accessed for treatment via a surgicalincision 208 made in the paramedian region lateral of the spinal canal210. A microdiscectomy procedure may precede the placement of atreatment device in order to remove disc fragments and may result in asubannular cavity. The cavity, however, may be preexisting or may becreated for the purpose of performing an adjunctive surgical procedure,such as a nuclear augmentation. A resulting aperture 214 in the annulusmay provide a path for the mesh or treatment device delivery tool 500 toplace treatment device 600. The treatment device 600 can take the formas described in commonly-assigned co-pending U.S. patent applicationSer. No. 11/120,750, filed on May 3, 2005 and Ser. No. 10/352,981, filedon Jan. 29, 2003 which are incorporated herein by reference, or anyother appropriate form. Likewise, the anchor band delivery device 400can take the form as described in the embodiments above, or asadditionally described below with reference to FIGS. 20-29, or asdescribed in commonly-assigned co-pending U.S. patent application Ser.No. 11/120,750 filed on May 3, 2005 and U.S. patent application Ser. No.10/327,106, filed on Dec. 24, 2002 now issued U.S. Pat. No. 7,004,970and incorporated herein by reference or any other appropriate form.

A patch delivery device 500 is introduced through surgical incision 208to traverse aperture 214 and position treatment device 600 in subannularcavity 212. The, treatment device 600 is in a first configuration sizedto permit its passage to the subannular cavity 212. FIG. 13 shows atransverse view of mesh device 600 mounted on the distal portion ofdelivery tool 500, introduced to the cavity and deployed.

The treatment device delivery tool 500 can be manipulated by, forexample, pulling a finger grip 502 to deploy treatment device 600. Thisdeployment may involve a longitudinal shortening of the treatment deviceresulting in a lateral expansion of the treatment device 600. Thepulling of the finger grip 502 may be preceded by the release of asafety lock preventing deployment of the treatment device until intendedby the surgeon. Also shown in FIG. 17 is a marking 538 on the deliverytool 500 that may visually assist the surgeon in assessing the degree towhich the device has been placed in subannular space.

Once the finger grip 502 reaches its intended limit, and the concomitantfull intended deployment of treatment device 600, the deployed device600 may then be pulled to internally engage and at least partiallyconform to the cavity 212. Naturally, the full travel of the finger grip502 can be determined by the design of the delivery device, or informedby the judgment of the surgeon through visualization, tactilerealization, or the like. Once the intended limit has been achieved andthe device fully deployed, the delivery device 500 can lock finger pull502 in place so as to maintain the treatment device 600 in the deployedconfiguration. It may also be advantageous for the delivery tool 500 tohave a perceptible (i.e., audible, tactile, visual) indication that thetreatment device has been fully deployed. The mesh/patch delivery tool500 may be of the type described hereinabove, or as additionallydescribed in other figures and/or sections of this disclosure.

As exemplified in FIGS. 13-19, a fixation element or anchor banddelivery device 400 may then be introduced through surgical incision208, where the distal end 402 is passed through the annulus fibrosus 202adjacent to the aperture 214, and subsequently through treatment device600. Fixation element delivery tool 400 may have features to providetactile feedback once the delivery tool has been introduced into tissueto an acceptable extent, for example a feature like tissue-stop 432. Asillustrated, delivery device 400 is passed distally until stop 432and/or pledget member 309 of the fixation apparatus 308 come in contactwith the outer surface of the annulus. Alternatively, and without tissuestop 432 use, pledget member 309 could be of construction to similarlyresist, or otherwise visually or tactilely indicate ceasing the passageof delivery device 400 through annular tissue. FIG. 17 shows a detail,sagittal view of a distal end of a fixation element delivery tool 400introduced into disc tissue and through treatment patch 600. As shown inFIG. 17, one fixation apparatus 308 has been deployed and fixated. FIG.17 also depicts an exemplary treatment device detection feature 442 onthe outer surface of needle cannula 428, as more clearly illustrated inFIG. 21. The patch detection feature 442 on the distal end of needlecannula 428 may advantageously provide perceptible feedback (tactileand/or audible) to the surgeon that the tissue anchor band delivery toolhas accessed and penetrated the patch and it is therefore acceptable todeliver the band. Feature 442 is discussed in more detail below. Inoperation as illustrated in FIG. 13, the delivery device 400 can bemanipulated similarly to the treatment device delivery tool. Forexample, moving finger grip 404 in the direction of arrow 304 willwithdraw a portion (for example, the slotted needle cannula 428) ofdistal end 402 of the delivery device 400 and deploy a fixation element308, as more described below, in the cavity 212 to secure the treatmentdevice 600. The pulling of the finger grip 404 may be preceded by therelease of a safety lock 406 preventing deployment of the fixationelement until intended by the surgeon. The fixation element deliverytool 400 may be of the type described hereinabove, or as additionallydescribed in FIGS. 20-29 below, or in other areas of this disclosure.

FIG. 13 depicts the deployment of a fixation element 308 into disctissue. The fixation device may be as described above, for instancecomprising T-anchors, sutures, tethers, knots, pledgets or barbs. Asillustrated here, the fixation element 308 is a T-anchor with suturebodies, knot, and pledget as more fully described below. During thepulling of finger grip 404 and retraction of slotted needle cannula 428,a knot pusher end 436 of inner cannula 426 is shown, for example in FIG.21, holding a proximal portion of the fixation device's 308 slip knot440, while T-anchor 316 is drawn in tension proximally by tether orsuture line 310, to adjust the length of the fixation element 308 toprovide the proper tension to securely hold the treatment device 600 insitu. A proximal end of the fixation element, such as a pledget 309, isheld or urged into engagement with a bearing surface on the exterior ofthe annulus. The proximal end of the fixation device can also include aT-anchor or knot or similar tissue locking element. FIG. 21 is across-sectional view of the distal end of delivery tool 400 as it may beintroduced in disc tissue. FIG. 28 shows the distal end of the deliverytool 400 after retraction of the slotted cannula 428 (as shown by arrow326 of FIG. 18), and tensioning and drawing T-anchor 316 proximally to apotential final state. The proximal drawing of T-anchor 316 is alsoillustrated in a detail, sagittal view in FIG. 18, with arrows 324illustrating motion of the T-anchor. The construction of the lockingelement 316 is exemplary and is not intended to be limiting ofalternative constructions of 316, such as one or more pledgets, knots,barbs or other forms to affect the same function of anchoring in tissue.

FIG. 14 shows the partial withdrawal of the fixation element deliverydevice once the fixation element has been deployed. In the illustrationsshown, the final step during the pulling of finger grip 404 proximallyresults in the release of the fixation element in situ. The release maybe accompanied by visual or tactile or auditory confirmation, such as aclick. Once released, the fixation element delivery tool can becompletely withdrawn as shown in FIG. 15, leaving the suture body 310 ofa fixation element extending through the surgical incision 208. Theproximal portion of suture body 310 may be cut to a suitable length withreadily available surgical tools such as a scalpel or surgical scissorsand removed from the surgical site. The fixation element 308 is fixedlyengaged with the disc tissue and the patch 600. FIG. 16 depicts thetreatment device 600 after placement of two fixation devices 308, asdoes FIG. 19 shown in a detail, sagittal view. Of course, any number offixation devices appropriate to secure the treatment device 600 can beused. It is also anticipated that device 600 may be of a constructionand design, as described herein, that does not necessitate anchor bandsto effect securement of device 600 within the disc space and therefore,illustrations using fixation elements are to be exemplary, and notlimiting. Once secured, the treatment device 600 is released from themesh delivery tool 500. This may be accomplished in a two or more stepprocess. For example, the release mechanism may be enabled by rotatingknob 506 in the direction of arrows 312. An indicator may then beactivated to notify the surgeon that the treatment device has beenreleased from the delivery tool 500. Accompanying the deployment ofindicator may be the uncoupling of the treatment device 600. Thedelivery tool 500 can then be withdrawn leaving treatment device 600 insitu.

FIGS. 20-29 depict illustrative embodiments of a fixation elementdelivery tool (or FEDT) as discussed above, which may be referred toalternatively as an anchor band delivery tool (or ABDT) or a fixationapparatus delivery apparatus. The fixation element 308 is depicted asloaded in the distal end 402 of the ABDT, which will be discussed ingreater detail with reference to FIG. 21. The ABDT 400 is comprised of amain body member 410 which may be fixedly attached distally to outercannula 422, and also to inner cannula 426 at inner cannula anchor 438.Distally, inner cannula 426, as better illustrated in detail in FIG. 21,may comprise a knot pusher 436 (or other means to effect securement ofsuture tethers 310 and 318 with locking element 440) and T-anchorstand-off 434. Proximally, main body 410 has disposed safety member 406with an outside diameter telescopically and rotatably received in theinner diameter of a knob 408. Knob 408 and main body member 410, may berigidly attached to one another. Slidably disposed within the lumen ofthe main body member 410 is suture retention block 414, depicted withelongate member body 310 threaded through its center hole. A spring 316may also be slidably disposed within the lumen of the main body memberand can abut either suture retention block 414 or slider member 418.Slider member 418 can be integral with finger grip 404 (shown in FIG.13). Attached to the proximal end of slider member 418 is a suturecutting blade assembly 420. The blade assembly, as will be discussed ingreater detail below, serves to sever the suture body 310 afterdeployment of the fixation elements as described herein. A slot in theslider member 418 allows the slider member 418 to slide past the cannula426 and, as described previously, 426 may be stationary with respect tomain body 410. A slotted needle cannula 428, slidably disposed in thelumen of the outer cannula 422, is secured to the distal end of slidermember 418 by needle cannula anchor 430, such that the translation ofthe slider member 418 within main body member 410 concomitantlytranslates the slotted hypotube 428 within the outer cannula 422.

FIG. 21 is a detailed view of the distal end 402 of the ABDT 400. Asdescribed above, the slotted hypotube 428 is slidably received in theouter cannula 422. A tether, consisting of a suture line 318 and apledget body 309 is located in proximity to an optional tissue stop 432on the outer cannula 422. It is also possible for pledget 309 to be heldby an optional outer cannula pledget holder 433 until release of theanchor band. The suture line 318 is slidably knotted to suture body 310.The distal end of suture body 310 is attached to T-anchor 316, which isheld by T-anchor stand off 434. As described above, T-anchor stand-off434 and knot pusher 436 may be components of inner cannula 426. In theinitial configuration, needle hypotube 428 extends distally of outercannula 422 and allows the point of slotted hypotube 428 to extenddistally of the T-anchor holder 434.

FIGS. 20 and 21 depict the ABDT in its initial delivery configuration.The ABDT is locked in this configuration by the distal end of safety 406engaging the finger grip 404 (not shown) as depicted in FIGS. 13 and 14.Rotation of handle member 406, as shown by arrow 306 in FIG. 23, mayallow the finger grip 404 to engage a slot on safety 406, and permit thesurgeon to pull finger grip 404 proximally toward the proximal knob 408.Doing so results in the translation of the slider member 418 proximally,and concomitantly, the proximal translation of the slotted needlecannula 426 (as a result of slotted needle cannula anchor 430) in thedirection of arrow 326 (illustrated in FIG. 18). The result, asdiscussed above, is the unsheathing by the needle 428 of T-anchor 316held by T-anchor holder 434. The translation of the slide body 418proximally also urges the spring 416 and suture retention block 414proximally. The suture retention block 414 is attached to suture body310, and therefore tension is leveraged onto the suture body 310 to holdit taught and, when appropriate, draw T-anchor 316 from within thedelivery tool to a position proximally.

FIGS. 23 and 24 illustrate the partial deployment of anchor bandassembly from ABDT, wherein slotted needle cannula 428 has beenpartially retracted to expose Tanchor 316. FIG. 22 is a detail,cross-sectional view of the distal end of the handle of ABDT 400,illustratively showing the inter-relationships of delivery toolcomponents in the initial configuration and FIG. 25 is a similar detail,cross-sectional view showing the inter-relationships after at least apartial deployment of device 400. FIG. 26 is a detail of the sutureretention body 414, suture body 310, spring 316 and cutting assemblyblade 420, during partial deployment of delivery tool 400, as discussedabove.

As depicted in FIG. 27 and detail drawings of FIGS. 28 and 29, as sliderbody 418 continues to slide proximally, in addition to continuing todraw T-anchor as shown in FIG. 28 with arrows, the tether retentionblock 414 reaches the limit of its proximal translation (discussedfurther below), and the slider member engages and compresses spring 316.As the spring is compressed, the blade assembly 420, which is alignedwith the hole of suture retention body 414 through which suture body 310passes, comes into engagement with the suture body 310. FIG. 29 is adetail view of the blade 420 severing the elongate member 310. Up to thelimit of travel of the suture block 414 and the severing of tether 310,the suture body 310 continues to apply tension to the T-anchor, as shownin greater detail in FIG. 28. With knot pusher holding knot 440, pledget309, and suture 318 in apposition, and in distally exerted fashion, tothe tensioning of suture body 310, fixation apparatus assembly 308 isadvantageously cinched into a fixing and/or compressive relationshipbetween ends 309 and 316, as well as any structures (e.g., nucleus,annulus, treatment device) between elements 309 and 316. After severingsuture body 310, suture body 310 is still attached to the anchor band,but has at this point been severed proximally. The suture body 310 willtherefore be unthreaded from the interior of the ABDT as the ABDT iswithdrawn. As discussed above the suture line 310 may be further cut tolength with readily available surgical scissors. Alternatively, asevering mechanism similar to those described herein within the distalportion of tool 400 may be employed to avoid an additional step oftrimming the end of body 310.

FIG. 26 is a detail of the suture retention body 414, suture body 310,spring 316 and cutting assembly blade 420, during partial deployment ofdelivery tool 400, as discussed above.

Additionally inventive of the anchor band device (and its delivery anddeployment tools) is the unique inter-relationship of the slide body,spring, and the tension delivered to the T-anchor and tissue duringdeployment. For example, T-anchor assembly can be designed to passthrough softer, or otherwise more pliable tissues (e.g., nucleuspulposus, softer annular layers) while resisting, under the sametension, passage through tougher tissues and/or substrates (e.g., outerannular layers, treatment device construct). In further illustrativedescription, tension delivered to the member line 310 can be limited bythe interface between the slide body member 318 and the suture retentionblock 414, through spring 316 such that tension is exerted on T-anchorbody 316 which may sufficiently allow movement of T-anchor 316 throughsofter tissue, but alternatively requires a greater force to pullT-anchor body through other materials or substrates such as thetreatment device 600 or outer layers of the annulus 202. Spring 316 canbe designed to sufficiently draw tissues and/or the patch together,while not overloading suture line 310 when the fixation has beeneffected. Spring 316 may also be advantageously designed to allow bladeassembly 420, upon reaching an appropriate loading to effect thedelivery, to sever the suture line 310. As illustrative example, but notintended to be limiting, T-anchor body and suture line may beconstructed to require approximately 5 pounds of force to draw theT-anchor assembly through nuclear tissue, but substantially greater loadto draw T-anchor through annular tissue and/or patch device. Spring maybe designed to exert approximately five (5) pounds, sufficiently pullingtissue anchor through nuclear tissue, and in proximity to treatmentdevice, as intended. Once sufficient load has been applied to moveT-anchor to engage patch, the loading on the suture line is not allowedto substantially increase. Advantageously, additional loading wouldcause the final compression of spring between suture retention block andblade assembly to sever suture line. Preferably, the severing and thedesign of the tether elements are such that the ultimate strength of thefilament line 310 is greater than the load required to draw an anchorthrough soft tissue, or the like, and less than the load inflicted tocause the severing by blade assembly. The description herein is intendedto be illustrative and not limiting, in that other device and deliverytools could be derived to employ the inventive embodiments.

With regards to introduction, delivery, deployment and/or fixation offixation element 308 as described previously and in particular, withregards to FIGS. 20-29, for example, anchor band assembly 308 and itsassociated delivery tool 400 may be described as effecting a fixation asshown in FIGS. 32A and 32B. FIG. 32A shows a pledget element 309 that,initially, may be placed on outer annular surface. As depicted, tether318 is attached to pledget 309, and pledget and tether are secured tosuture line 310 via a slip knot 440, for example. During deployment,T-anchor is drawn toward, and engaged with, treatment device 600 asillustrated in FIG. 32B. There may be alternative methods and mechanismsof drawing together locking elements/tissue anchors 309 and 316, asexemplified in FIG. 31. FIGS. 31A and 31B illustrate a T-anchor member316 that may be positioned, initially, in proximity of patch 600. Asdepicted, tether 318 is attached to T-anchor, and T-anchor and tetherare secured to suture line 310 via a slip knot 440, for example. Duringdeployment, pledget 309 may be drawn to, and engage with, the surface ofouter annulus tissue, as illustrated in FIG. 31B. The description ofmethods of drawing members together and effecting a fixation of afixation element with its fixation element delivery tools are intendedto be illustrative, and not limiting in the scope of the invention.

Since the surgeon's visualization during discectomy procedures istypically limited to the epi-annular space and the aperture at theoutside surface of the annulus, any tactile, visual or audible signalsto assist, or otherwise enhance, the surgeon's ability to reliablydeliver and deploy treatment devices and/or anchor bands may beadvantageous. The tissue anchor band delivery tool 400, may have a patchdetection feature 442 on the distal end of slotted needle cannula 428which may provide perceptible feedback (tactile and/or audible) to thesurgeon that the fixation apparatus delivery tool has accessed andpenetrated the patch and it is therefore acceptable to deliver the band.As shown, detection feature 442 is composed of multiple bands or ribsalong the outer surface of needle 428. The movement of the ribs of 442against the patch structure (e.g., the filaments of treatment device600) may produce a clicking sound and feel, and the interface of thecomponents of the devices and tools may be optimally designed to enhancesuch feedback features. One, or multiple, ribs or tabs may be utilizedto achieve the perceptible features. The feed back may be perceived onor with the patch and/or patch delivery tool or through the anchor bandand/or anchor band delivery tool, or both. FIGS. 30A-30C illustrativelyshow additional means that may be attached to the anchor band or anchorband delivery tool which might also provide perceptible feedback. Thesedepictions are meant to be illustrative and not limiting in scope of theinvention. FIG. 30A shows a tab 442 attached to needle cannula 428 whichmay be laser cut from the distal end of needle 428. Detection tab 442may be designed to readily pass through soft tissue and the patch 600without causing significant disruption, but may be capable due to itsdesign construction to produce tactile and/or audible sensation as itengages the patch lattice or structure. Lateral extent of tab 442 ofFIG. 30A may advantageously deflect, or otherwise deform or bend towardthe distal end of needle cannula upon removal of the delivery tool so asnot to be restricted by the lattice or structure of treatment device 600upon its removal. Alternatively, detection tab 442 of FIG. 30B isaffixed to, or integral with, T-anchor 316. Similarly, detection tab 442may be designed to readily pass through soft tissue and treatment device600 without causing significant disruption, but may be capable ofproducing tactile and/or audible sensation as it engages the patchlattice or structure. In this embodiment, tab 442 advantageously remainswith T-anchor 316 after removal of delivery tool 400. Moreover, it ispossible to have a detection feature 442 as depicted in FIG. 30C,wherein the feature is wholly, or partially, coaxial disposed on thedelivery tool and feature 442 may be of a construction that does notreadily pass through patch 600, but it is capable of passing throughsoft tissue of the disc and produce a tactile and/or audible sensationas it engages the patch lattice or structure. Although some of theembodiments illustrate a single tab or rib, it is possible to use morethan a single element. Detection features described herein may be of avariety of shapes and affixed to the devices or delivery tools (forexample, welding ribs onto the surface of the delivery tool, affixing aflexible filament member to the T-anchor) or be incorporated as anintegral component thereof (for example, laser cutting or stamping tabsout of a portion of needle 428, injection molding tabs as part ofT-anchor 316). Exemplary materials that could be used to construct thevarious detection features include, but are not limited to:biocompatible polymeric materials (polyester, polypropylene,polyethylene, polyimides and derivatives thereof (e.g., polyetherimide),polyamide and derivatives thereof (e.g., polyphthalamide), polyketonesand derivatives thereof (e.g., PEEK, PAEK, PEKK), PET, polycarbonate,acrylic, polyurethane, polycarbonate urethane, acetates and derivativesthereof (e.g., acetal copolymer), polysulfones and derivatives thereof(e.g., polyphenylsulfone), or biocompatible metallic materials(stainless steel, nickel titanium, titanium, cobalt chromium, platinumand its alloys, gold and its alloys).

As generally illustrated in the following FIGS. 33A to 46F, alternativeembodiments of present inventions include various additional fixationdelivery apparatus described previously as, for example, 400 will now befurther described by 400 in FIGS. 32A-46F and associated methods.Fixation delivery apparatus in accordance with the present inventionsmay permit the placement of a fixation apparatus described previously asfor example, 308 and 100 will now be further described by 100 in FIGS.32A-46F and within an intervertebral disc of a patient. Typically, thefixation delivery apparatus may be configured to deliver one or moreanchors described previously as, for example, 916, 709, 316, 309 and nowwill be further described by 102 in FIGS. 33A-46F of a fixationapparatus 100 into and/or through an intervertebral disc, which mayinclude the annulus fibrosus, the nucleus pulposus, vertebral bodies andsurrounding connective tissues. The fixation delivery apparatus 100 maybe configured to deliver multiple anchors 102, for example, a firstanchor 112 to a first location on an intervertebral disc and a secondanchor 122 to a second location on the intervertebral disc. The anchors102 are typically interconnected by one or more elongate membersdescribed previously as, for example, 144, 142, 710, 709, 910, 310, 318and now will be further described by 104 in FIGS. 33A-46F, such asbands, sutures, wires, and cables for example, which may be cinched,tightened, reduced, or otherwise shortened so as to reduce the length ofthe connection between at least a first anchor 112 and a second anchor122. Two or more elongate members 104 may include retention devicesand/or knots 108 described previously as, for example, 145, 714, 914,440 to interconnect the members and to permit the cinching of theelongate members 104. The cinching of the elongate members 104 mayreconstruct, retain, stabilize, re-approximate and/or draw togethertissues surrounding a defect, tear, cut or delamination in the tissuesof an intervertebral disc of a patient.

As generally illustrated throughout the FIGS. 33A-46A, fixation deliveryapparatus 400 generally includes a delivery apparatus body 12, one ormore shafts 14, actuators 16, and displacement rods 18. The deliveryapparatus body 12 is typically secured to one or more shafts 14 to allowa surgeon to position the distal end of the shaft 14 within anintervertebral disc of a patient. Each shaft 14 may define a lumen 24and/or slot 34 which may removably receive at least a portion of atleast one anchor 102 and or connecting band or loop 110, 104. Adisplacement rod 18 may be positioned through at least a portion of thelumen 24 and/or slot 34. A displacement rod 18 may be axially slidablealong at least a portion of the lumen 24 and/or slot 34 of a shaft 14. Adisplacement rod 18 may communicate with anchor 102 and/or fixationapparatus 100 to displace an anchor 102 from the lumen 24 and/or slot 34of a shaft 14. An actuator 16 may be movable by a user relative to adelivery apparatus body 12. The actuator 16 may be in communication witha displacement rod 18 to confer movement of the displacement rod 18within the lumen 24 and/or slot 34 of a shaft 14 such that at least oneanchor 102 may be expelled from the lumen 24 and/or slot 34 of the shaft14 while the distal portion of the shaft 14 is positioned proximateand/or within an intervertebral disc of a patient and the deliveryapparatus body 12 and actuator 16 maybe positioned at least partiallyexternal to the patient to allow actuation by a surgeon.

In one aspect, a fixation delivery apparatus 400 may include a singleshaft 14. The shaft 14 may define a lumen 24 and/or slot 34 to seriallyreceive two or more anchors 102. The tissue anchors 102 may besequentially dispensed from the distal end of the shaft 14 at one ormore locations within an intervertebral disc. In this embodiment, thedistally positioned anchor 102 may be particularly referred to as thefirst anchor 112 and the proximally positioned anchor 102 may beparticularly referred to as the second anchor 122. The anchors 102 aredisplaced from the lumen 24 and/or slot 34 of the shaft 14 by adisplacement rod 18. A displacement rod 18 may communicate with anactuator 16 so that a user may advance a displacement rod 18 within thelumen 24 and/or slot 34 to dispense anchors 102 from the lumen 24 and/orslot 34 of the shaft 14. The first anchor 112 may be sized to befrictionally held within the lumen 24 and/or slot 34, may be retained inthe lumen 24 and/or slot 34 by one or more detents formed within thelumen 24 and/or slot 34, may be retained in the lumen 24 and/or slot 34by an elongated member 104 or other interconnecting members betweenanchors 102 and/or tethers 124, or may be otherwise temporarily securedto the lumen 24 and/or slot 34 of shaft 14. The second anchor 122 may besimilarly secured to shaft 14 in a manner similar to a first anchor 112or, alternatively, may be tethered by a tether 28 to retain a secondanchor 112 secured to lumen 24 and/or slot 34 during and/or afterdisplacement of the first anchor 112 into the intervertebral disc of apatient. In one aspect, the tether 28 may be secured to the displacementrod 18 or the actuator 16. Before, or upon, or after placement of thesecond anchor 122, the tether 28 may be severed, broken, cut orotherwise released from an actuator 16, displacement rod 18, and/or thedelivery apparatus body 12 or shaft 14 to permit the release of thesecond anchor 122 from the structure to which the tether 28 is secured.In this exemplary embodiment, the first anchor 112 can be displaced fromthe shaft 14 by movement of the displacement rod 18 a first distancesufficient to displace the first anchor 112. This first distance may beinsufficient to displace the second anchor 122. Then, the shaft 14 ofthe fixation delivery apparatus 400 may be moved from the first locationwhere the first anchor 112 was dispensed and repositioned at a secondlocation on or in the intervertebral disc to dispense the second anchor122. The second anchor 122 may be connected to the first anchor 112 byone or more loops 110 and/or elongate members 104.

In another aspect, a fixation delivery apparatus 400 may include two ormore shafts 14. In an exemplary embodiment, wherein there are twoshafts, (similar to, for example, FIG. 10), one shaft 14 may beparticularly referred to as the first shaft and the other shaft 14 maybe particularly referred to as the second shaft. The first shaft and thesecond shaft may be adjacent one another and could be parallel to oneanother over at least a portion of their length. Each shaft 14 maydefine a lumen 24 and/or slot 34 to receive one or more anchors 102. Invarious configurations, the anchors 102 may be simultaneously orsequentially dispensed at one or more locations within an intervertebraldisc from the distal end of the respective shaft 14 in which the anchors102 are positioned. In this embodiment, the anchor 102 positioned in thefirst shaft may be particularly referred to as the first anchor 112 andthe anchor 102 positioned in the second shaft may be particularlyreferred to as the second anchor 122. In this embodiment, a first anchor112 can be displaced from the first shaft by movement of a firstdisplacement rod 118 a distance sufficient to displace the first anchor112 from the lumen 24 and/or slot 34 of the first shaft. A second anchor122 may be displaced from the second shaft by movement of a seconddisplacement rod a distance sufficient to displace the second anchor 122from the lumen 24 and/or slot 34 of the second shaft. The firstdisplacement rod 118 and second displacement rod may communicate withone or more actuators 16 to simultaneously or sequentially dispense thefirst anchor 112 and the second anchor 122 from the respective lumen 24and/or slot 34 in which they are secured. The second anchor 122 istypically connected to the first anchor 112 by one or more loops 110and/or elongate members 104. The first anchor 112 and the second anchor122 may be sized to be frictionally held within the respective lumen 24and/or slot 34 of first shaft and second shaft, may be retained in therespective lumen 24 and/or slot 34 by one or more detent within thelumen 24 and/or slot 34 or may be otherwise temporarily secured withinthe lumen 24 and/or slot 34 as described previously.

The delivery apparatus body 12 may be generally configured to provide auser with a structure to manipulate the distal portion of the shaft 14within a patient. The delivery apparatus body 12 may have an elongatedform and define a longitudinal aspect. In one aspect the proximalportion of the shaft 14 may be secured to a distal portion of thedelivery apparatus body 12. When the shaft 14 is secured to the deliveryapparatus body 12, the longitudinal axis of the shaft 12 may be coaxialwith the longitudinal axis of the delivery apparatus body 12. In oneaspect, the delivery apparatus body 12 may include a handle 40 integralwith the body, or secured to the delivery apparatus body 12. Whensecured to the delivery apparatus body 12, the handle 40 may be securedto the outer surface of the delivery apparatus body 12. The handle 12 istypically positioned to facilitate the manipulation of the fixationdelivery apparatus 400 by a surgeon and may be particularly configuredto assist the surgeon in the positioning and/or dispensing of a fixationapparatus 100 within a patient. In another aspect, the deliveryapparatus body 12 may include a raised textured surface for increasedfriction between a user's hands and the fixation delivery apparatus 400.The delivery apparatus body 12 may further cooperate with the actuator16 to control the movement of the displacement rod 18 within a lumen 24and/or slot 34 of shaft 14. In another aspect, the delivery apparatusbody 12 may define a body cavity 22 to movably receive the actuator 16.The delivery apparatus body 12 may also comprise a tether access portal30 as a primary or secondary structure to access and/or sever the tether28 to facilitate the release of the fixation apparatus 100.

The delivery apparatus body 12 may be formed from a metal, polymericmaterial or other material that will be recognized by those skilled inthe art upon review of the present disclosure. Some exemplary suitablematerials recognized by those skilled in the art, include among others,polymers, such as acrylic polymers polyurethane, polycarbonate,engineered plastics; and metals, such as stainless steel and titanium.

The shaft 14 may be an elongate member that could be secured to anddistally extend from the delivery apparatus body 12. Although thevarious embodiments described and illustrated herein typically define adelivery device 400 configuration that extends along a longitudinalaxis, it is contemplated that the shaft and/or device components couldextend along different projections so as to provide better visualizationof the distal portions of the instruments within the surgical site. Forexample, it is possible that the handle and/or the proximal portion ofshaft 14 define a longitudinal axis that is at a different angle than,for example, the distal portion of shaft 14. With this configuration,the handle, in use, may extend from the surgical site at a lateralposition from the access incision and provide better visualization ofthe distal portion of shaft 14 within the surgical site. The shaft 14may define a lumen 24 and/or slot 34 in at least a distal portion of theshaft 14. The lumen 24 and/or slot 34 may be configured to releasablysecure one or more anchors 102, or portions thereof The lumen 24 and/orslot 34 may be particularly sized and shaped to receive anchors 102 andthe associated connecting loops 110 and/or elongate members 104, orportions thereof The slots 34 may permit various components of theanchors 102 and/or elongate members 104 (including components of anchors102, loops 110 or elongated members 104 such as retention devices and/orknots 108 or retention members, for example) to extend from the shaft 14at a distal portion of the shaft 14. In one aspect, the lumen 24 and/orslot 34 may extend from the proximal end to the distal end of the shaft14. In this configuration, the lumen 24 and/or slot 34 may communicatewith the body cavity 22 of the delivery apparatus body 12 at a proximalportion of the shaft 14. In one aspect, the lumen 24 and/or slot 34 maybe configured to slidably receive a filament 28. The lumen 24 and/orslot 34 may extend distally to about the distal portion of shaft 14 andmay extend to the distal tip of the shaft 14. The lumen 24 and/or slot34 of the shaft 14 may have a circular, elliptical, hexagonal,pentagonal square, diamond, rectangular, triangular, or other crosssectional shape and may be configured to releasably receive at least aportion of an anchor 102. In one aspect, the cross sectional shape ofthe lumen 24 and/or slot 34 may correspond to the cross-sectional shapeof the anchor 102. In one aspect, the lumen 24 and/or slot 34 of shaft14 may have a cross-sectional shape suitable to accommodate adisplacement rod 18 and at least one anchor 102, or portion thereof. Thelumen 24 and/or slot 34 may have the same or a varying configurationalong their length.

The distal tip of the shaft 14 may be generally configured to permit theshaft 14 to penetrate the surface of an intervertebral disc using aforce exerted by a surgeon on the delivery apparatus. In one aspect, thedistal tip of the shaft 14 may include a sharpened tip. In anotheraspect, the distal tip of the shaft 14 may be chamfered to provide apoint which may be sharpened to accommodate insertion through at least aportion of the annulus fibrosus of an intervertebral disc. In oneembodiment, the distal tip of the shaft 14 may be cut obliquely to forma sharp leading surface or point for ease of insertion. In oneembodiment, the tip may be serrated in order to accommodate delivery ofthe apparatus into and/or through boney tissue, such as the vertebralbodies.

A sheath 43 may be provided over at least a portion of the length of theshaft 14. The sheath 43 may function to reinforce the shaft 14. Inalternative embodiments, the sheath 43 may provide a change in diameterlongitudinally along the shaft 14 such that the penetration of theannulus fibrosus may be inhibited as the leading edge of the sheath 43contacts the annulus. In another aspect, the shaft may include a tissuestop 54 positioned relative to the distal end of the shaft 14 to inhibitthe penetration of the annulus fibrosus. Typically, the tissue stop 54may inhibit the penetration of the annulus fibrosus by providing aregion of the shaft 14 with increased surface area. The tissue stop 54may be typically sized and shaped to efficiently inhibit the penetrationof the shaft 14 through the annulus fibrosus while being relativelyatraumatic to the tissues which it may contact.

The distal portion of the shaft 14 may include a tactile indicatorsimilar, as an example, to 442 of FIG. 21 to indicate that the distaltip of the shaft 14 has penetrated the intervertebral disc and/or apatch 600 in the case where a reparative fixation apparatus 100 is usedin conjunction with a reparative patch 600. The tactile indicator 442may be integrally formed from the material of the shaft 14 or may besecured to the shaft 14 to provide a tactile indication of properpenetration. Typically, the tactile indicator 442 is provided on anouter surface of the shaft 14, although it is possible for indicator tobe provided on other components of the delivery apparatus, such as thesheath 43 and/or the fixations apparatus, such as the anchors 102, aspreviously described in FIG. 30. The tactile indicator 442 may comprisea series of ribs on the outer surface of the shaft 14 or may comprise anexternal arm configured to “click” to an extended position when theshaft 14 enters an area of increased diameter or a region of softermaterial within a patient.

The shaft 14 is typically from about 1 inch to 10 inches long. However,the length of the shaft 14 may vary considerably depending upon theconfiguration of the fixation apparatus 100 and the fixation deliveryapparatus 400, and may vary particularly depending upon theconfiguration of the delivery apparatus body 12 to which the shaft 14may be secured, as well as the technique used to access theintervertebral disc space. The shaft 14 may be made from a wide range ofmaterials having the desired performance characteristics depending, atleast in part, on the overall configuration of the fixation deliveryapparatus 400 and may include: metals, such as stainless steel,nickel-titanium alloy, and titanium; plastics, such as PTFE,polypropylene, PEEK, polyethylene, and polyurethane, acrylic,polycarbonate, engineering plastics; and/or composites.

The displacement rod 18 may confer a motive force to anchors 102 todisplace one or more of the anchors 102 from the lumen 24 and/or slot 34of the shaft 14. In some embodiments, the displacement rod may alsofunction to withdraw one or more anchors 102 into the lumen 24 and/orslot 34. A portion of the displacement rod 18 may communicate withanchors 102 which may be least partially positioned within the lumen 24and/or slot 34 of shaft 14. In one aspect, the displacement rod 18extends through at least a portion of lumen 24 and/or slot 34. Thedisplacement rod 18 may be slidably received within the lumen 24 and/orslot 34. In one aspect, the displacement rod 18 may be of a size andcross-sectional shape to correspond with the size and/or internal shapeof the lumen 24 and/or slot 34 in which at least a portion of thedisplacement rod 18 may be received. Although the characteristic of thedisplacement rod 18 may be typically of a unitary structure, adisplacement rod 18 in accordance with the present invention may includemultiple components which act in conjunction with one another todisplace the anchors 102 from the shaft 14.

In one embodiment, the displacement rod 18 may define a displacement rodlumen 26. In one aspect, the displacement rod lumen 26 may extend from aproximal portion to a distal portion of the displacement rod 18. Thedisplacement rod lumen 26 may communicate with the body cavity 22 of thedelivery apparatus body 12 at a proximal portion of the displacement rod18. In one aspect, the displacement rod lumen 26 may be configured toreceive a tether line, suture, wire, filament or otherwise elongatemember. Tether 28 can be formed of multiple materials and/or componentsto perform its function. In addition, a tether passage 38 may be definedin the wall along the proximal portion of the displacement rod 18. Thetether passage 38 may permit a portion of tether 28 to exit adisplacement rod lumen 26 at a proximal location or a location distal tothe proximal end of the displacement rod lumen 26. The proximal portionof the displacement rod 18 may communicate with actuator 16 to actuateor regulate the movement of the displacement rod 18. In one embodiment,a proximal portion of the displacement rod 18 may be secured to actuator16. The distal portion of the displacement rod 18 may typicallycommunicate with at least one anchor 102. In one aspect, the distal endof the displacement rod 18 may communicate with the proximal end ofanchor 102 to confer a motive force to the anchor 102.

In one exemplary embodiment, the displacement rod 18 can be advanceddistally a first distance, sufficient to dispense a first anchor 112.The shaft 14 of the fixation delivery apparatus 400 may be then removedfrom the first insertion point in the intervertebral disc and insertedinto the intervertebral disc at a second insertion point, where thedisplacement rod 18 may then be advanced distally a second distance todispense a second anchor 122, and so-on as may be desired for more thantwo anchors 102. Alternatively, for simultaneous delivery of multipleanchors 102, multiple shafts 14, each including a displacement rod 18,may be provided on the fixation delivery apparatus 400 and may bearranged adjacent to, parallel or substantially parallel along a portionof their lengths. In such configurations, the distance between theshafts 14 may be fixed or inter-operatively adjustable, as desired. Whenadjustable, the fixation delivery apparatus 400 may include a mechanism,such as a ratchet or displacement mechanism (not shown), or otherwise,as will be recognized by those skilled in the art upon review of thepresent disclosure, to adjust the distances between the distal portionsof the shafts 14. The multiple shaft embodiment may also be additionallyconfigured for sequential displacement of anchors 102.

An actuator 16 may communicate with one or more displacement rods 18 orcomponents thereof to assist a user in advancing the displacement rods18 along the respective shafts 14. The actuator 16 may be configured asan enlarged body residing at the proximal portion of displacement rod 18which may be integral with, or secured to the displacement rod 18 toassist a user in advancing displacement rod 18. In this aspect, thedistance the displacement rod 18 is pushed to define a first, second,and subsequent distances may be regulated by feel. Alternatively, thedistance can be regulated by the architecture of the device. In thisaspect, the actuator 16 may cooperate with the delivery apparatus body12 to control the advancing and/or retracting of the displacement rod 18within shaft 14, for example as shown in FIG. 33.

Exemplary cooperation of actuator 16 and body 12 as shown in FIG. 33,the actuator 16 and delivery apparatus body 12 may cooperate by having aguide 32, such as a pin or projection for example, on one component thatis slidably received in a groove 36 or similar guide receiving apparatusof the other component. In one such configuration, the guide 32 may beformed in, or positioned in the body and/or the body cavity 22 of thedelivery apparatus and a groove 36 may be defined by the outer surfaceof the actuator 16. The groove 36 may extend longitudinally along andcircumferentially (or laterally depending upon the actuator's shape)around the actuator 16. The actuator 16 may be slidably positioned inthe body cavity 22 of the delivery apparatus body 12 such that the guide32 is received within the groove 36. The guide 32 extending from thebody cavity 22 may be aligned within a groove 36 in the actuator 16defined on the surface of actuator 16 such that the guide 32 is slidablyreceived within the groove 36 and tracks the groove 36 as the actuator16 is moved within the body cavity 22. Thus, when the displacement rod18 is mechanically secured to actuator 16, wherein the movement of theactuator 16 corresponds one to one with the movement of the displacementrod 18, the movement of the displacement rod 18 will correspond to theconfiguration of the groove 36 on the actuator 16.

Fixation apparatus 100 as described herein may be various constructsutilized as primary reparative treatment of the soft tissues of thespine wherein re-approximation, reinforcement, stabilization, retention,reconstruction, and/or fixation as it would be otherwise achieved may benecessary for prophylactic or therapeutic repair of a defect, aperture,weakened, thinned or infirmed portion of the disc including the annulusfibrosus. In addition, fixation apparatus 100 described herein may beutilized in combination with other treatment constructs 600 such aspatches, membranes, scaffolds, barriers, stents (used interchangeably)wherein fixation devices may additionally enable a treatment device 600to be affixed to the soft tissue, including the annulus fibrosus, of thespine.

Fixation apparatus 100 may contain two or more anchors 102 and one ormore elongate members 104 or may contain one or more anchors 102, one ormore pledgets 309 and one or more elongate members 104. Furthermore, itis understood that multiple fixation apparatuses 100 may be usedtogether to perform a repair or other procedure. Anchors 102 maygenerally be configured to maintain a position within an intervertebraldisc as forces are applied to the elongate members 104. The one or moreelongate members 104 may typically be connected to a first anchor 112and a second anchor 122, or an anchor 102 and a pledget 309 and may beconfigured to apply a force between the first anchor 112 and the secondanchor 122 or the anchor 102 and the pledget 309, while allowing thecomponents to be drawn toward one another. One of the elongate members104 may be elongated and may function as a cinch line 124 that isaccessible to a surgeon after implantation of the anchors 102 of thefixation apparatus 100. In operation, the elongate members 104 securedbetween the anchors 102 may allow drawing together disc tissue, such asthe annulus, between the anchors 102 when tightened. Accordingly, thefixation apparatus 100 can be placed in tension applying a force to pulltogether, wholly or partially, the surrounding tissue of theintervertebral disc. The forces may be applied to reapproximate,reinforce, retain, reconstruct or otherwise fix a tear, defect,incision, rent and/or delamination in the intervertebral disc of apatient.

Anchors 102 are generally configured to substantially maintain a desiredposition within and/or on an intervertebral disc as tension is appliedto a band 104 or multiple elongate members 104 securing two or moreanchors 102 together. The anchors 102 are typically configured to permittheir positioning within and/or on an intervertebral disc using afixation delivery apparatus 400 and, once positioned and secured, toresist movement within the intervertebral disc. The anchors 102 may beconfigured as barbed anchors, T-anchors, coiled anchors, darts, conical,elliptical or other configurations as will be recognized by thoseskilled in the art upon review of the present disclosure. In anexemplary embodiment a barbed anchor 102 may include an elongated bodyhaving at least one barb extending laterally from its longitudinal axis.One end of the elongated body may be particularly configured topenetrate the tissues of an intervertebral disc when the anchor 102 isdirected through tissue in a direction along its longitudinal axis. Inan exemplary embodiment, an anchor 102 may be connected to an elongatedbody, band 104, filament, filament loop or eyelet 110 secured at, nearor proximate its midpoint such that, after insertion in a longitudinalorientation, the anchor 102 tends to assume a position perpendicular toa line of force exerted by the loops 110 and/or band 104. Loops oreyelets 110 may be a rigid structure or may be a flexible structuredefining a loop through which a band 104 may be positioned. In oneaspect, the eyelets 110 are integral with or secured to the anchor 102and are a rigid structure. In another aspect, the eyelets 110 aresecured to the anchors 102 and are a flexible structure such as a wire,filament, line, tether or suture, for example. In an exemplaryembodiment of a coiled anchor, a anchor 102 may include an elongatedbody in the form of a coil that is formed from flexible and resilientmaterial such that it may be insertable from a lumen 24 and/or slot 34in a shaft 14 in a substantially straightened or collapsed position andonce dispensed from the shaft may resume its original shape. In analternative exemplary embodiment of a coiled anchor, an anchor 102 mayinclude an open-wound, helically configured rigid element that may beattachably connected to the distal end of the shaft 14. Rotation of theshaft 14 or displacement rod 18 may, for example, advantageously “screw”the coiled anchor into tissue of an intervertebral disc.

The anchors 102 may be elongated in shape. The anchors 102 may beintegral with or secured to elongate members 104. The elongate members104 can be secured to the anchors 102 through loops or eyelets 110 whichmay be integral with or attached to the anchors 102, can be secured tothe anchor 102 through band passages extending into or through theanchors 102. In one aspect, a band passage may extend through the anchor102 perpendicular to or substantially perpendicular to the longitudinalaxis of the anchor 102. In other aspect, the band passage may extendthrough the anchor 102 at other angles relative to the longitudinal axisof the anchor 102. Typically, the anchors 102 will be configured topermit at least partial placement within a lumen 24 and/or slot 34 ofthe shaft 14 of a fixation delivery apparatus 400. Alternatively, anchor102 may have a defined cavity or passage to permit anchor 102 to bepositioned at least partially over the distal tip of shaft 14 of afixation delivery apparatus 400. In this alternative embodiment, anchor102 may have a surface configured to pierce the soft tissue of theintervertebral disc and allow delivery of the anchor 102.

The anchors 102 are typically formed from a substantially biocompatiblematerial of a metallic or polymeric biocompatible material such as, forexample, titanium, NiTi alloy, stainless steel, platinum, gold,polyurethane, polycarbonate urethane, polyimide, polyamide,polypropylene, polyethylene, polypropylene, polyester, PET, or PEEK, orcould be constructed from a biodegradable/bioabsorbable material suchas, for example, collagen, silk, cellulose, polysaccharides,carbohydrates, polyglycolic acid, polylevolactic acid, polydioxanone, orracemic polylactic acid. In addition, the anchors 102 can be constructedof a combination of these materials.

One or more elongate members 104 may interconnect anchors 102 and/orpledgets 309 of fixation apparatus 100. At a first end or region, theelongate members 104 may secured to one or more anchors 102. Theelongate members 104 may be tied to the anchors 102, may be mechanicallysecured to the anchors, may be integral with the anchors 102 or may beotherwise secured to the anchors as will be recognized by those skilledin the art upon review of the present disclosure. In one aspect, one ormore anchors 102 may be slidably secured to the elongate members 104 ormay be slidably received over the elongate members 104. Typically, oneor more elongate members 104 may be tied to one another with one or moreretention devices and/or knots 108 that may permit the cinching (orshortening) of the length of elongate members 104 separating two or moreof the anchors 102. The retention devices and/or knots 108 in the bandare typically movable along one of the elongate members 104 but may bemovable along two or more elongate members 104. The retention devicesand/or knots 108 are typically positioned between the anchors 102. Onesuitable family of retention devices and/or knots 108 include, but arenot limited to, the Roeder knot 108 and its functional equivalents.These knots may be pre-tied during the assembly of a fixation apparatus100. Alternatively, a mechanical element slidably received over a firstband 104 and secured to the end of another band 104 which is lockable ina desired position over the first band 104 may also be used. In anotheraspect, two or more anchors 102 may include loops or eyelets 110 whichmay be comprised of looped elongate members 104 through which a band 104in the form of a cinchable loop or “lasso” may be passed. The cinchingof the elongate members 104, or a loop in a band 104, allows fortaking-up slack and drawing towards one another intervertebral disctissues so as to reapproximate, retain, reinforce or otherwise repairtissues surrounding a disc tear, incision, defect, rent, infirmation ordelamination.

As noted previously, the elongate members 104 may be formed from avariety of materials. In one aspect, the elongate members 104 may beformed from sutures or suture materials commonly used by surgeons. Theelongate members 104 may be configured to have sufficient strength tore-approximate or draw together tissue surrounding tear, rent, incision,defect or delamination in the annulus fibrosus of a patient. In oneaspect, the elongate members 104 may be substantially inelastic to,among other things, permit a surgeon to sufficiently retain or draw thetissue of the intervertebral disc together by cinching the elongatemembers 104. In another aspect, the elongate members 104 may be formedfrom an elastic material and configured to be in a stretched positionupon implantation in a patient to apply a closing force to a defect inan annulus fibrosus of a patient. The elasticity of the elongate members104 may also be selected to substantially correspond to that of theintervertebral disc of the patient. The elongate members 104 may bestring-like filaments having a construction and dimension, as disclosedherein and as will be understood by those skilled in the art upon reviewof the present disclosure, that are amenable to the delivery to andrepair of the intervertebral disc, as well as engagement with thefixation apparatus 100. For example, an elongate member 104 may have awidth greater than, in some embodiments far greater than, its thickness.When the elongate member 104 is formed from a suture or similarfilamentous material, the elongate member 104 may, in some embodiments,have a width/height ratio of 1.25:1. In some embodiments, elongatemembers 104 may be constructed, wholly or partially, of a mesh tube.Moreover, different segments along the length of the band may havedifferent dimensions and constructions. For example, the elongate member104 may be constructed of thin material, such as nickel titanium alloyor stainless steel wire, close to the anchor, while the middle portionthat may span the aperture may comprise a much wider band made ofoptionally softer material and/or a material that has a surface textureor porosity conducive to fibrotic ingrowth and repair or may beotherwise configured as disclosed elsewhere in the present disclosureand/or as will be understood by those skilled in the art upon review ofthe present disclosure.

A patch-like device 600 in the form of a patch, membrane, scaffold,barrier, stent, sealing device, reinforcement, plug, occlusion device,or otherwise, may be provided for repair, reconstruction, reinforcement,re-approximation, or otherwise treatment of apertures, weakened, thinnedor otherwise infirmed tissue such as tears, rents, defects,delaminations and/or incisions within an intervertebral disc. In oneembodiment, an apparatus 600 may used in combination with otherreparative apparatuses, such as fixation apparatus 100, for there-approximating, reinforcing, or otherwise repairing tissues.Particularly, it is conceivable that some natural and surgically madedefects may be relatively large and accordingly, reapproximation oftissues surrounding an aperture is not actually or practically possiblewithout the introduction of additional material. A device 600 inaccordance with the present inventions may provide the material forpositioning in and around a defect to bridge some, all or a portion ofthe defect to facilitate a medically appropriate stabilization of thetissues. The patch 600 may function to reinforce the portion of anintervertebral disc through which a fixation apparatus 100 is implanted.And, patch 600 may be used to bridge tissues of a defect and may alsoact as a scaffold for tissue ingrowth.

The patch 600 may be configured as a membrane, webbing, mesh,scaffolding, barrier or otherwise as will be recognized by those skilledin the art upon review of the present disclosure. The patch 600 may beof a rigid construction, may be flaccid, or may of an intermediaterigidity. The patch may also have configurations that include multiplerigidities associated with different portions of the patch as may benecessary to address alternative defect pathologies and/or delivery anddeployment considerations. The patch 600 may be of a solid material,webbing or otherwise, or may comprise one or more mounting cavities 610within the patch. In one aspect, the mounting cavities or receptacles610 may cooperate with a patch insertion tool 500 to assist in theplacement of the patch 600. In one aspect, the patch 600 defines asingle patch mounting cavity 610 extending along its length and,accordingly, may be configured as a sleeve or a sock. In alternativeembodiments, the patch 600 may define a plurality of mounting cavities610 which are configured to receive one or more projections, brackets,arms or otherwise mounting or retaining elements 504 or 506 of the patchinsertion tool 500.

Patches 600 can be formed from a variety of materials or combinations ofmaterials known to those skilled in the art. These materials aretypically biocompatible. The patch 600 may be configured from natural orsynthetic materials including, but not limited to, various polymers,metals and biological tissues, for example. In one aspect, the patch 600may be formed from autograft para-spinal fascial tissue, xenograft,allograft, or other natural or processed collagenous materials. Thematerial could also be polymeric such as a Dacron (polyester, or PET),polypropylene, polyethylene, polymethylmethacrylate, silicone, PTFE,ePTFE, Surlyn, or PEBAX material, for example. In some exemplaryembodiments, the patch 600 could comprise biocompatible metal, such asNiTi alloy, chromium cobalt alloy, titanium, stainless steel or thelike. Webbing materials could also be woven or non-woven, or braided.Patches may also be partially or wholly constructed from biodegradeableor bioabsorbable materials. It is also possible for the patches to beconstructed, partially or wholly, from previously herein describedmaterials, as well as to comprise of one or more of these materials, asmay be generally understood by those skilled in the art. Patches mayalso comprise bioactive materials and may also be for mechanical,biochemical and medicinal purposes. The patch 600 may also be drugeluting, as known in the medical implant arts. Furthermore, in oneexemplary embodiment, the material of the patch 600 may contain astructure sufficient to readily permit the passage of the distal portionof a shaft 14 of a fixation delivery apparatus 400 with little or noresistance while providing resistance to the dislodging of an anchor 102dispensed within or through patch 600.

Patch delivery tools 500 in accordance with the present inventions aregenerally configured to position one or more patches 600 at positions inproximity, adjacent or within an intervertebral disk 200 of a patient.Typically, patch delivery tools 500 are configured to releasably securedevices 600 on or about the distal portions of delivery tools 500 suchthat, after a surgeon has secured at least a portion of the patch 600 tothe intervertebral disk 200 of a patient, the patch 600 may be releasedfrom the patch delivery tool 500 and the patch delivery tool 500 may beremoved from the patient.

A patch insertion tool 500 may be provided in accordance with aspects ofthe present inventions. The patch insertion tool 500 may include anelongated body 502. The proximal end of the elongated body 502 maygenerally be configured to be manipulated by a surgeon. The distal endof the elongated body 502 may generally be configured to releasably holdpatch 600 for positioning in, on, about, and/or across a defect, tear,rent, delamination or incision in an intervertebral disc. Although thevarious embodiments described and illustrated herein typically define apatch delivery device 500 configuration that extends along alongitudinal axis, it is contemplated that the shaft and/or devicecomponents could extend along different projections so as to providebetter visualization of the distal portions of the instruments withinthe surgical site. For example, it is possible that the handle and/orthe proximal portion of elongate body 502 defines a longitudinal axisthat is at a different angle than, for example, the distal portion ofelongate body 502. With this configuration, the proximal portion, inuse, may extend from the surgical site at a lateral position from theaccess incision 208 and provide better visualization of the distalportion of body 502 within the surgical site.

The patch insertion tool 500 may further include one or more guides 508between the proximal and distal end to receive at least a portion ofshaft 14 or any other components of fixation delivery apparatus 400and/or a patch retention line 512. One or more patch retaining arms 504and/or 506 may extend generally laterally from a longitudinal axis ofthe patch insertion tool. The patch retaining arms 504 and/or 506 may begenerally configured to retain a patch and typically may define gap 514and/or 516, respectively. For example, gap 514 may be generallyconfigured to permit the passage of a shaft 14, or other component, of afixation delivery apparatus 400 through the gap 514. Gap 514 may bepositioned on the patch retaining arm 504 and aligned with guide 508 toaid in the proper positioning of a fixation apparatus 100 and itsdelivery tool 400. In operation, the shaft 14 of fixation deliveryapparatus 400 may extend through the patch 600 at the location securedover the gap 514 of the patch retaining arm 504. The location of the gap514 selected such that the fixation apparatus 100 adequately secures thepatch 600 to the intervertebral disc when it is delivered and deployed.Two or more patch retaining arms 504 may be positioned along or aboutthe elongated body 502 of the patch delivery tool 500. Variousembodiments of patch delivery tool 500 configurations and theirrespective parts, including body 502, guides 508, arms 504, 506 and gaps514, 516 are illustratively shown in FIGS. 34A to 36A. In an alternativeembodiment, the patch retaining arms, for example 504 and 506, may befixed or adjustable and/or movable relative to the elongated body 502.In one aspect, the longitudinal spacing between two or more patchretaining arms 504, 506 may be adjustable to allow the patch retainingarms to accommodate various sized patches 600 and/or various anatomicalfeatures of the intervertebral disc 200 being treated. One suchadjustable embodiment is illustratively shown in FIG. 37. Moreover, itis possible that the length of arms 504, 506 that emanate from body 502may be adjustable (not shown) and may allow the lateral projection ofarms 504, 506 from body 502 to be increased and/or decreased before orduring the delivery and deployment of patch 600 so as to accommodatevarious anatomical features of the intervertebral disc to be repaired.These adjustments may be advantageously made through a mechanism (notshown) residing within or adjacent body 502 that adjustably allows therelease of arms from body 502 wherein the release may be controlled oractuated by the surgeon, as required, by an actuator (not shown)residing on the proximal portion of delivery apparatus 500.

Patch retaining arms 504, 506 may also define one or more patchretaining line passages 534, 536 or patch retaining line grooves 544,546 to secure patch 600 onto and/or over one or more of the patchretaining arms 504, 506.

FIGS. 33A to 33D illustrate exemplary embodiments of a fixation deliveryapparatus 400 in accordance with aspects of the present inventions. Asparticularly illustrated in FIGS. 33A to 33D, the fixation deliveryapparatus 400 may include a delivery apparatus body 12, shaft 14,actuator 16, and a displacement rod 18. The illustrated fixationdelivery apparatus 400 may be configured to accommodate and sequentiallydeploy two or more anchors 102 of one or more fixation apparatuses 100.The illustrated fixation delivery apparatus may include a mechanism forregulating the advancing of displacement rod 18 for release of the twoor more anchors 102 of a fixation apparatus 100 from the shaft 14. Theembodiments of the fixation delivery apparatus 400 illustrated in FIGS.33A to 33D are for exemplary purposes only. Any description of theseparticular figures not written in the permissive form is merely toexplain the nature and relationship of the particular components of theillustrated embodiments and is in no way intended to limit thedisclosure to the particularly illustrated components.

The delivery apparatus body 12 may include a body cavity 22 within atleast a portion of the delivery apparatus body 12. The deliveryapparatus body 12 may be elongated and include a handle 40 at theproximal portion of the delivery apparatus body 12. The shaft 14 may besecured to the distal portion of the delivery apparatus body 12. Aguide, pin, or projection 32 may extend into the body cavity 22 and maybe received by slot or groove 36 of actuator 16.

The shaft 14 extends from delivery apparatus body 12 and may include asheath 43. The shaft 14 may comprise a lumen 24 which may extend fromthe proximal portion to the distal portion of shaft 14. The lumen 24 isillustrated with a circular cross-sectional shape that may be suitableto accommodate the circular cross-sectional shape of the illustratedanchors 102 and to slidably receive displacement rod 18, although,alternative cross-sectional configurations could be employed toaccomplish the same function. The lumen 24 of the shaft 14 may be incommunication with body cavity 22 of the delivery apparatus body 12 andmay permit the at least one displacement rod 18 and/or its components tobe slidably received within shaft 14. As illustrated, the distal tip ofthe shaft 14 may be cut obliquely to form a sharp leading surface orpoint for ease of insertion into an intervertebral disc. The shaft 14may include a slot 34 along its side to accommodate portions of fixationapparatus 100, such as elongate members 104, 110 and anchors 102, andknots 108 that may not reside completely within lumen 24.

The actuator 16 and/or the displacement rod 18 may be movably receivedwithin a portion of body cavity 22. As illustrated, the actuator 16 mayfunction as a handle to interface with a user and extends proximallyfrom the proximal end of the delivery apparatus body 12. A distalportion of the actuator 16 may be secured to a proximal portion ofdisplacement rod 18. The displacement rod 18 is particularly shown assecured to the distal portion of the actuator 16. The actuator 16 mayconfigured to advance displacement rod 18 in a 1 to 1 ratio. Adisplacement spring 20 may be positioned within the body cavity 22between the distal portion of body cavity 22 and the distal portion ofactuator 16, in the example shown. The displacement spring 20 may biasthe illustrated actuator 16 and displacement rod 18 in a proximaldirection. A groove 36 on actuator 16 may be configured to cooperatewith the projection 32 of the delivery apparatus body 12. Those skilledin the art would realize this is an exemplary configuration and, forexample, groove 36 could as easily be located on the apparatus body 12and the pin 32 could reside on the actuator 18.

The displacement rod 18 may generally be configured to apply a motiveforce to dispense t-anchors 102 from the distal end of the lumen 24and/or slot 34. The displacement rod, as shown, is an elongatedstructure having a substantially circular cross-sectional shape and maycomprise a displacement rod lumen 26 extending along at least a portionof the length of the displacement rod 18. At least a distal portion ofthe displacement rod 18 may be slidably received within the lumen 24 ofthe shaft 14. The movement of the displacement rod 18 within lumen 24may be modulated by actuator 16. As particularly illustrated, theactuator 16 is configured to advance the displacement rod 18 in a 1 to 1ratio. A tether passage 38 may be defined in a proximal portion of thedisplacement rod 18. The tether passage 38 may permit a portion oftether 28 to extend from the displacement rod lumen 26 to be positionedwithin body cavity 22 of the delivery apparatus body 12. Although tether28 here is used as a general term, those skilled in the art wouldrecognize that tether 28 could be a wire, string, suture band or otherelongate member to satisfy the same purpose.

The tether 28 may be provided to secure an anchor 102 prior todeployment. The proximal portion of tether 28 may be secured to theactuator 16, displacement rod 18, and/or delivery apparatus body 12. Asillustrated, the tether 28 is secured to a portion of the actuator 16.More particularly, the distal portion of the actuator 16 defines aflange 88 about which tether 28 is looped around the flange 88 to securethe proximal end of the tether to the actuator 16. Advantageously, thedistal end of the actuator 16 may have a tether severing cavity 48 whichincludes a lip 68. In addition, a tether severing element 58 may beprovided in the distal portion of the body cavity 22. The tethersevering element 58 may include a cutting edge 78. The tether severingcavity 48 and the tether severing element 58 may cooperate to sever thetether 28 and thus allow anchor 102 to be released from lumen 24 and/orslot 34. As illustrated, the tether 28 is cut by positioning theactuator 16 distally with the passage 38 and the lip 68 of tethersevering cavity 48 overlapping the longitudinal axis of the cutting edge78 of the tether severing element 58 to press the tether 28 against thecutting edge 78. Alternatively, if an automated cutting feature is notused, a tether access portal 30 may be provided through the deliveryapparatus body to permit access to the tether 28 with other cuttingdevices such as scissors or scalpels for example.

A sheath 43 may be secured about the outer surface of shaft 14. Thesheath 43 may extend from the delivery apparatus body 12 to a locationproximal to the distal end of shaft 14. A tissue stop 54 may be securedto the distal portion of shaft 14. As illustrated, the tissue stop 54may also be particularly secured on sheath 43. The shaft 14 may furtherdefine a slot 34. Slot 34 may be configured to slidably receivecomponents of fixation apparatus 100 as the components slide along thelongitudinal axis of the shaft 14. As illustrated in FIG. 33B, eyelets110 comprised of looped elongate members 104 or filaments extend fromthe slot 34 and loops 110 are interconnected by an adjustable elongatemember 104, such as a cinch line 124 as shown.

The illustrated fixation apparatus 100 include three anchors 102 in FIG.33A and two anchors 102 in FIG. 33B. The anchors 102 are sequentially atleast partially positioned in a lumen 24 of shaft 14. As illustrated,the anchors 102 are configured as T-anchors, although those skilled inthe art would recognize other anchor configurations are possible toachieve the same effect. Each anchor 102 defines a transverse passagewhich receives a portion of a connecting member 104. As illustrated,elongate connecting member 104 comprises a filament loop or eyelet 110.As illustrated, filament loops or eyelets 110 are flexible lines formedinto loops which are secured within the transverse passages of theanchors by enlarged knotted portions. Also, shown, the filament loops110 extend through the slot 34 from first anchor 112, the second anchor122, and, when present, the third anchor 132 and are interconnected byan additional elongate band 104 formed into a loop which passes throughthe passages defined by each of the eyelets 110. The band 104 connectingthe implanted anchors 102 with their eyelets 110 includes a moveableknot 108 which permits foreshortening of band 104. With foreshorteningof band 104, a trailing end of cinch line 124 may become longer as slackis removed from the loop of band 104. A portion of band 104 may havesufficient length to extend outside the patient and form a cinch line124 which is accessible by a surgeon after implantation. A pull or tab70 may be secured to the cinch line 124 to more easily facilitate thelocating and/or manipulating of the cinch line 124. The pull 70 may beremovably securable to the shaft 14, as illustrated, or the deliveryapparatus body 12. Pull tab 70 may also be advantageously coupled (notshown) to body 12, displacement rod 18, and/or actuator 16 so as tolimit to ability to slideably dispense anchors 102 until and/or when thesurgeon desires; at which time, removal of pull tab 70 may allowdispensing of one or more anchors 102. In addition, a cinch line holder80 may be provided on the delivery apparatus body 12, pull tab 70, shaft14, or a combination of components of apparatus 400 so as to allow forline management during the delivery and deployment of fixation apparatus100. Holder 80 may include features that resistively allow controlleddispensing of line 124 during anchor deployment to assist in themanagement of the cinch line 124 during a surgical procedure. Resistanceon line 124 could be accomplished by the selective sizing of holder 80with respect to line 124. Alternatively, knotted elements (not shown)along line 124 could be received within holder 80 that comprisesmechanical interlocking components (not shown) so as to resistivelyimpede and provide controlled dispensing of line 124. These are intendedto be illustrative examples of causing resistance and control of line124 and should not be interpreted as being limiting as those skilled inthe art would recognize a variety of ways to accomplish a similareffect.

As illustrated in FIG. 33D, a mechanism for regulating movement ofdisplacement rod 18 may generally include a guide 32 extending into bodycavity 22 and a groove 36 defined on the surface of the actuator 16. Theguide 32 on the delivery apparatus body 12 cooperates with the groove 36on the actuator 16 and may regulate at least the axial movement of thedisplacement rod 18.

The guide, pin or projection 32 may be slidably received in groove 36 ofthe actuator 16. The guide 32 may be secured to or within the bodycavity 22 of the delivery apparatus body 12. As illustrated, in FIG.33D, guide 32 is positioned within a guide cavity 62 and includes aguide spring 52 biasing the guide 32 outward into the body cavity 22.The illustrated guide 32 includes a flange which abuts a cavity flangeon a portion of the guide cavity 62 to prevent the guide 32 from beingdisplaced from the guide cavity 62. Note that guide 32, spring 52, body12 and their cooperative relationship with groove 36 may alsoadvantageously allow for tactile and/or auditory feedback to the surgeonduring delivery of anchors as guide 32 passes along groove 36. Inalternative embodiments, the guide 32 could be otherwise rigidly ormovably secured within the body cavity 22 without departing from thescope of this aspect of the present inventions.

As illustrated in FIG. 33D, the groove 36 may extend along the outersurface of the actuator 16. The groove 36 may include longitudinallyextending portions 46 and radial extending portions 56. Thelongitudinally extending portions 46 may allow for longitudinaladvancing the actuator 16 and associated displacement rod 18. Theradially extending portions may function to stop the longitudinaladvancing of the actuator 16 and associated displacement rod 18. Thegroove 36 may also include a step 66 wherein the depth of the groove 36increases. When the guide 32 is biased within the groove 36 for example,the step 66 could prevent, for example, further proximal withdrawal ofthe actuator 16 and/or the displacement rod 18 from the body cavity 22beyond the point where the guide 32 contacts the step 66.

In operation, the guide 32 may be initially positioned within a safetylock position 76 where the displacement rod 18 may be in a most proximalposition with respect to shaft 14 and wherein the actuator 16 may bebiased in a proximal position with respect to shaft 14 and/or by thedisplacement spring 20, as seen in FIG. 33C. The tip of the shaft 14 ofthe fixation delivery apparatus 400 may be positioned adjacent to afirst location for insertion of the first anchor 112. The tip of theshaft 14 is inserted at the first location and the shaft 14 is advancedinto the intervertebral disc. In the illustrated embodiment, the motiveforce is typically applied to the delivery apparatus body 12 by thesurgeon. The shaft 14 may be advanced until the distal aspect of thetissue stop 54 contacts an outer surface of the intervertebral disc orthe tip of the shaft 14 has otherwise been determined to be at thedesired location within the intervertebral disc. The surgeon may notethat the shaft 14 has been properly advanced by the resistance tofurther movement resulting from the stop 54 or sheath 43 contacting theouter surface of the intervertebral disc. Once properly positioned, thedisplacement rod 18 may be advanced relative to the delivery apparatusbody 12 by the surgeon to displace the first anchor 112 from the tip ofthe shaft 14 into the intervertebral disc. To do this, the surgeon maydistally displace the actuator 16 relative to the body cavity 22 torelease the guide 32 from the safety lock position 76. The actuator maythen be rotated approximately 90 degrees sliding the guide 32 through afirst radially extending portion 56 of the groove 36. The surgeon maythen advance the actuator 16 distally within the cavity 22 which mayslide the guide 32 through the first longitudinal extending portion 46of groove 36. This movement of the actuator may displace the firstanchor 112 from the lumen 24 and/or slot 34 of shaft 14 by distallyadvancing the displacement rod 18 a first distance. The first distanceis selected to be sufficient to displace the first anchor 112, but to beinsufficient to eject the second anchor 122. As the guide 32 reaches theproximal portion of the first longitudinal extending portion 46 ofgroove 36, the guide 32 may pass over step 66 and extend further intogroove 36 due to forces exerted on the guide 32 by guide spring 52. Asseen in FIG. 33D, the first longitudinal extending portion 46 of groove36 may extend proximally beyond the second radially extending portion 56of groove 36 to assure proper displacement of the first anchor 112 fromshaft 14. A surgeon would have to apply sufficient force to the actuator16 to slide the guide 32 to the most proximal portion of the firstlongitudinal extending portion 46 of groove 36. Once the surgeon removesthe distally extending force on the actuator, the actuator is forced ina proximal direction by the displacement spring 20 until guide 32contacts the step 66 preventing further proximal movement of theactuator 16 relative to delivery apparatus body 12. This proximal motionof the actuator 16 may function to draw the tethered second anchor 122proximally in lumen 24 and/or slot 34 of shaft 14 dispensing the firstanchor 112 from lumen 24. After the first anchor 112 has been positionedat the first location within the intervertebral disc, the shaft 14 ofthe fixation delivery apparatus 400 may be withdrawn from the firstlocation. The first anchor 112 is left secured within the intervertebraldisc.

The second anchor 122 and fixation delivery apparatus 400 may remainsecured to the first anchor 112 connecting bands 104 such as 104, 110and/or trailing cinch line 124 of elongate bands, as shown in FIG. 33B.A loop in elongate member 104 may be configured to be at least longenough to extend from a first anchor location to a second anchorlocation prior to cinching band 104. The tip of shaft 14 of the fixationdelivery apparatus 400 may be then repositioned adjacent to a secondlocation on the intervertebral disc for insertion of the second anchor122. The tip of the shaft 14 is inserted at the second location and theshaft 14 is again advanced into the intervertebral disc. The shaft 14may again be advanced until the distal aspect of the tissue stop 54 orsheath 43 contacts an outer surface of the intervertebral disc or thetip of the shaft 14 has otherwise been determined to be at the desiredlocation within the intervertebral disc. Once properly positioned, thedisplacement rod 18 may be advanced relative to the delivery apparatusbody 12 by the surgeon to displace the second anchor 122 from the tip ofthe shaft 14 into the intervertebral disc. To do this, the surgeon mayrotate the actuator approximately 90 degrees by sliding the guide 32through a second radially extending portion 56 of the groove 36. Thesurgeon may then advance the actuator 16 distally within cavity 22 whichmay slide the guide 32 through the second longitudinal extending portion46 of groove 36. The movement of the actuator may displace the secondanchor 122 from the distal portion of shaft 14 by distally advancing thedisplacement rod 18 a second distance. The second distance beingselected to be sufficient to displace the second anchor 122 from thelumen 24 and/or slot 34 of the shaft 14 into the intervertebral disc.The surgeon then removes the shaft 14 from the intervertebral discleaving the second anchor 122 at the second anchor location within theintervertebral disc.

After insertion of at least the first anchor 112 and the second anchor122, the loop of elongate member 104 is shortened by hand or by pushingon, for example, a slip knot 108 with a knot-pusher or similar device toapply a force to the knot to slide the knot along the band 104 andreduce the size of the loop which tends to draw towards one another theanchors 102 and adjacent tissues surrounding an annular defect.Typically, the tightening is managed using a cinch line 124 that can bemanipulated by the surgeon. Once tightened, the excess cinch line 124can be cut.

It is contemplated that one or more fixation apparatuses 100 (and theirrespective delivery apparatuses 400) as illustratively described andshown in FIGS. 33A to 33D could be used to effect annular repairs asfurther illustrated in, for example, FIGS. 44A to 44E, but without theuse of patch-like device 600 (and its respective delivery tool 500), asis currently depicted in FIGS. 44A to 44E. It is possible that someannular defects may be readily repaired without the use of a patch-likedevice 600 and could advantageously be mended or otherwise repaired,partially or wholly, through tissue approximation. Exemplary of are-approximation without a patch-like device could be performed with oneor more repair apparatuses 100 comprising anchors 102, loops 110, bands104, retainers 108 and tethers 124, for example. And it could bedelivered via delivery device 400 as described previously and as ispartially illustrated as shaft 14 in FIGS. 44B and 44C. In thisalternative embodiment, tissues surrounding an annular defect may beadvantageously drawn towards one another to effect a repair, aspreviously described with respect to, for example, FIGS. 7 to 12. One,two or more fixation apparatuses 100 may be used to accomplish therepair. These apparatuses may be positioned along an annular aperture ormay be conveniently placed in a non-lineal fashion, such as a cruciateacross the annular rent. It is also possible, given alternativepresentations of annular defects, that a re-approximation could also beperformed that is similar to that of FIG. 6 wherein fixation apparatuses100 may be used in conjunction with a filler material 716 and withoutpatch 600 present. In this alternative embodiment, fill material 716 maybe directly affixed, or otherwise secured, to portions of one or morefixation devices 100 so as to retain filler material 716 in proximity ofthe annular defect.

Furthermore, it is conceivable that, in order to repair anintervertebral disc annulus that is damaged, degenerated or otherwiseinfirmed with defects of a circumferential and/or delaminatedphysiology, one might employ one or more fixation devices 100 so as todraw together or otherwise radially stabilize or retain tissues in areparative fashion. In this alternative embodiment (which may beadditional or further described in co-pending application Ser. No.11/120,750) there may not be an annular aperture readily apparent in theintervertebral disc, but rather the degenerative pathology may berecognized as high intensity zones under radiological examination, suchas for example MRI and CT scans. It is also possible, given this type ofrepair, that the anchors 102 of apparatus 100 may be placed at spatiallyfar greater distances apart (prior to foreshortening band 104) than maybe needed for repair of annular apertures. For example, it isconceivable to repair some large posterior protrusions and/ordelaminations of an annulus that anchors 102 could be deployed as farapart as the total posterior, or more, of the annulus so as toreparatively restore or otherwise stabilize the incompetent annulartissue.

Alternative embodiments wherein one or more patches 600 (and theirdelivery tools 500) and one or more fixation apparatuses 100 (and theirdelivery tools 400) may be used cooperatively, in a reparative fashion,are further described in FIGS. 43 to 46.

FIGS. 34A to 42D illustrate some exemplary embodiments of patch deliverytools 500 in accordance with aspects of the present inventions. Thepatch delivery tools 500 in accordance with aspects of the presentinventions are generally configured to deliver, deploy or otherwiseposition a patch 600 in proximity adjacent or otherwise partially orwholly within an intervertebral disk 200 of a patient. Moreparticularly, a treatment delivery apparatus 500 in accordance withaspects of the present inventions may be generally configured toposition a patch 600 in, on, through, about, and/or across a defecttear, rent, incision or delamination of an intervertebral disc.Typically, patch delivery tools 500 are configured to releasably securepatch 600 on a distal portion of delivery tool 500 such that after asurgeon has secured at least a portion of the patch 600 to theintervertebral disk 200 of a patient, the patch 600 may be released fromthe patch delivery tool 500 and the patch delivery tool 500 may beremoved from the patient.

The illustrated patch insertion tools 500 of FIGS. 34 to 46 generallyinclude an elongated body 502 and at least a distal patch retaining arm504. A proximal end of the elongated body 502 may include a handle ormay otherwise be configured to allow a surgeon to manipulate the patchinsertion tool 500 during a surgical procedure on an intervertebral discof a patient. The distal patch retaining arm 504 may extend from thelongitudinal axis of the elongated body 502 and is generally configuredto releasably secure or otherwise retain at least one patch 600 forimplantation into a patient. The patch delivery tool 500 may alsoinclude a proximal patch retaining arm 506. The proximal patch retainingarm 506 may also extend from the longitudinal axis of the elongated body502 and may be generally configured to releasably secure or otherwiseretain a patch 600 for implantation into a patient. In one aspect, thedistal patch retaining arm 504 and the proximal patch retaining arm 506may be generally parallel to one another along a portion of theirextension.

As particularly illustrated in FIGS. 34A to 36B, the distal scaffoldretaining arm 504 and, when present, the proximal scaffold retaining arm506 may be generally configured to be received within one or morescaffold mounting cavities 610 of scaffold 600 to secure the scaffold600 over the distal scaffold retaining arm 504 and the proximal scaffoldretaining arm 506. A guide 508 may be positioned proximally to thedistal scaffold retaining arm 504. The guide 508 may be configured toguide shaft 14, or other portion of a fixation delivery apparatus 400,to scaffold 600 for introduction of a fixation apparatus 100. Guide 508may also be configured to accommodate a scaffold retention line 512 soas to retain the scaffold 600 to at least the distal patch retainingarms 504. Guide 508 may also be configured to perform both functions.

The distal patch retaining arm 504 illustrated in FIGS. 34A to 36B and,when present, proximal patch retaining arm 506 may extend laterally froma longitudinal axis of a portion of elongated body 502 to which thedistal patch retaining arm 504 and the proximal patch retaining arm 506may emanate. The distal patch retaining arm 504 and the proximal patchretaining arm 506 may be configured to independently, or cooperativelysecure a patch 600 in a manner which permits the anchoring of a patch onand/or in an intervertebral disc. The distal patch retaining arm 504 andproximal patch retaining arm 506 may be sized and shaped to bepositioned on, in or about an intervertebral disc after being guidedthrough an incision 208 in a patient. The distal patch retaining arm 504and proximal patch retaining arm 506 are spaced apart along thelongitudinal axis of the elongated body 502. The distal patch retainingarm 504 and proximal patch retaining arm 506 may be fixed or movablerelative to the elongated body 502 as illustrated in FIG. 37. Asillustrated the distal patch retaining arm 504 and proximal patchretaining arm 506 may extend outwardly within a plane that may besubstantially perpendicular to the longitudinal axis of the elongatedbody 502, for exemplary purposes. The distal patch retaining arm 504 andthe proximal patch retaining arm 506 may define a distal patch retainingarm gap 514 and a proximal patch retaining arm gap 516, respectively. Asillustrated, the distal patch retaining arm 504 may generally beconfigured to suspend a portion of a patch 600 across the distal patchretaining arm gap 514 to permit a shaft 14 of a fixation deliveryapparatus 400 to penetrate the portion of patch 600 suspended over thepatch retaining arm gap 514. Similarly, the proximal patch retaining arm506 may generally be configured to suspend another portion of patch 600across a portion of the proximal patch retaining arm gap 516 to permitshaft 14, or other component of a fixation delivery apparatus 400, topenetrate a portion of the patch 600 suspended across patch retainingarm gap 516. In one embodiment, the distal patch retaining arm gap 514of arm 504 may be aligned with the proximal patch retaining arm gap 516of arm 506 along an axis which may be substantially parallel to thelongitudinal axis of the elongated body 502. Such an alignment maypermit a shaft 14, or other component of a fixation delivery apparatus400, to be directed through the portions of the patch 600 suspendedbetween both the patch retaining arm gaps 516 and 514, while followingan axis of insertion substantially parallel to the longitudinal axis ofthe elongated body 502.

An alternative embodiment particularly illustrated in FIG. 37 is a patchinsertion tool 500 with a distal patch retaining arm 504 and a proximalpatch retaining arm 506 which are adjustably spaced along thelongitudinal axis of the elongated body 502. A range of mechanisms foradjusting the spacing of the distal patch retaining arm 504 and aproximal patch retaining arm 506 will be recognized by those skilled inthe art upon review of the present disclosure. For exemplary purposes,the exemplary mechanism includes the distal patch retaining arm 504secured in a position relative to the elongated body 502. Asillustrated, the exemplary proximal patch retaining arm 506 isconfigured as two separate components, a first proximal arm portion 506′and a second proximal arm portion 506″. The first proximal arm portion506′ may be secured to a first proximal arm mount 556. The secondproximal arm portion 506″ may be secured to a second proximal arm mount566. Both the first proximal arm mount 556 and the second proximal armmount 566 may be movably attached to elongated body 502. In one aspect,the first proximal arm mount 556 and the second proximal arm mount 566may be independently slidably secured to the elongated body 502. Inoperation, the distance between the distal patch retaining arm 504 andthe proximal patch retaining arm 506 may be increased as the firstproximal arm mount 556 and the second proximal arm mount 566 are movedproximally along the longitudinal axis of the elongated body 502. Thedistance between the distal patch retaining arm 504 and the proximalpatch retaining arm 506 may be decreased as the first proximal arm mount556 and the second proximal arm mount 566 are moved distally along thelongitudinal axis of the elongated body 502 (see arrow in FIG. 37). Themovement of the first proximal arm mount 556 and the second proximal armmount 566 may be independent or dependent upon the movement of the otherdepending upon the configuration of the mechanism used as will berecognized by those skilled in the art upon review of the presentdisclosure.

Although treatment delivery tool 500 and retaining arms 504, 506 aregenerally depicted with rectangular configurations, it is clear thatalternative configurations (e.g., circular, elliptical, tubular,curvilinear) could be employed to accomplish similar effects.Furthermore, it is also clear that delivery tool 500 components may beconstructed of multiple materials and/or components to accomplish thesame objectives. In addition, guide 508 of apparatus 500 may havealternative forms such as eyelets, holes and tubes illustrated in FIG.34-36. Guides 508 may also have cut-outs or other similar features (notshown) that allow for passing fixation delivery apparatus 400 laterallythrough the side of the guide structure 508 rather than being limited topassing the apparatus 400 solely along the longitudinal axis of patchdelivery tool 500.

Although the modality of arms 504 and 506 has been represented with onealternative embodiment incorporating groves on 504 and 506 to retainpatch to delivery tool 500, alternative patch securement facilities asdiscussed herein could also be employed.

Alternative embodiments of a patch delivery tool 500 as illustrated inFIGS. 38A to 38C, may include a patch 600 secured by a distal retainingarm 504 and a proximal retaining arm 506. The patch 600 may be securedwithin retaining grooves 524 and 526 of the distal patch retaining arm504 and proximal patch retaining arm 506, respectfully. The retaininggrooves 524 and 526 may be positioned on opposing sides of patchretaining arm gaps 514 and 516. The patch retaining grooves 524 and 526may be generally configured to receive and releasably secure a portionof patch 600. The portion of the patch 600 may be compressionally,adhesively, mechanically (such as with detents, for example), orotherwise held within the patch retaining grooves 524 and, when present,the proximal peripheral patch retaining grooves 526, as will berecognized by those skilled in the art upon review of the presentdisclosure. The distal patch retaining grooves 524 are illustrated assecuring a distal portion 604 of patch 600. The distal portion 604 ofthe patch 600 may be secured across a portion of the arm gap 514 of thedistal retaining arm 504. The proximal patch retaining grooves 526 arealso illustrated as securing a proximal portion of patch 600. Theproximal portion 606 of patch 600 also may be secured across a portionarm gap 516 of the proximal retaining arm 506. The distal and proximalportions of patch 600 may typically be secured such that a portion ofdistal patch portion 604 and/or proximal patch portion 606 of patch 600may be anchored by a fixation apparatus 100 (or 308 as discussedpreviously) as delivered and deployed by fixation delivery apparatus400.

As illustrated in FIGS. 39A to 39E, a patch insertion tool 500 mayinclude a patch 600 secured over a distal retaining arm 504 and aproximal retaining arm 506. The illustrated patch 600 includes at leasttwo patch cavities 610 that are configured to be received over one ormore of the distal patch retaining arms 504 and the proximal patchretaining arms 506. The patch 600 is shown with a distal patch cavity610 receiving at least a portion of the distal patch retaining arm 504and a proximal patch cavity 610 receiving at least a portion of theproximal patch retaining arm 506. In addition, a patch retention line512 is provided to facilitate the securement of patch 600 over thedistal patch retaining arm 504 and the proximal patch retaining arm 506.The distal patch retaining arm 504 defines at least one distal patchretaining grooves 544 (not shown) and the proximal patch retaining arm506 defines at least one proximal patch retaining line groove 546extending from the elongated body 502. The distal patch retaining linegrooves 544 and the proximal patch retaining line passages 546 aregenerally configured to receive one or more patch retaining lines 512that have been threaded through a patch 600 one or more times. Theproximal patch retaining arm 506 is shown defining two proximal patchretaining line grooves 546 including one on each side of the proximalpatch retaining arm gap 516. As shown in FIG. 39C, a first patchretaining line 512 may extend along a first proximal patch retainingline groove 546, then pass through a proximal portion 606 of the patch600, then extend over a portion of an outer surface of the patch 600,and then be threaded through the patch 600, and then extend along asecond proximal patch retaining line groove 546. Similarly, a secondpatch retaining line 512 may pass along a first distal patch retainingline groove 544, then pass through a distal portion 604 of the patch600, then extend over a portion of an outer surface of the patch 600,and then be threaded through the patch 600, and then extend along asecond distal patch retaining line groove 544. Both the first and thesecond retaining lines may be secured at the distal portion of theinsertion tool 500 and/or, as illustrated for exemplary purposes, mayextend proximally along the elongated body 502 to permit a surgeon tomanipulate the lines before, during or after use of delivery tool 500.To release the lines, one or more knots in the patch retaining line 512may be untied, the patch retaining lines 512 may be cut, and/or one endof the patch retaining line 512 may be pulled to slide the patchretaining lines 512 out of patch 600 and/or the insertion tool 500. Onceremoved, cut or otherwise released, the patch 600 may be slid off of thedistal retaining arm 504 and a proximal retaining arm 506 eithersimultaneously or sequentially.

As illustrated in FIGS. 40A to 40E, a patch insertion tool 500 mayinclude a mesh 600 retained by a apparatus 500 with only a single distalretaining arm 504. The illustrated patch 600 includes a single patchcavity 610 that is configured to be received over the distal patchretaining arm 504. The patch 600 is shown with the distal patch cavity610 receiving the entire length of the distal patch retaining arm 504and extending proximally along a length of the elongated body 502,although it is also possible that only portions of tool 500 and arms 504are covered by patch 600. In addition, a patch retention line 512 may beprovided to retain the patch 600 over elongated body 502 and the distalpatch retaining arm 504. One or more patch retaining lines 512 may bethreaded through patch 600 one or more times at a proximal location ofthe patch and may be configured to retain a proximal portion of patch600 at a desired location along the elongated body. As illustrated, thepatch retaining line 512 may be threaded through a proximal portion 606of the patch 600, then extend over a portion of an outer surface of thepatch 600, and then again threaded through the patch 600, after whichthe patch retaining line 512 is secured relative to the elongated body.It is possible to thread alternative portions of patch 600, as well asit is possible that multiple retention lines 512 may be used. The patchretaining line 512 may be releasably secured at the distal portion ofthe insertion tool 500 or, as illustrated for exemplary purposes, mayextend proximally along the elongated body 502. To release the lines,one or more knots in the patch retaining line 512 may be untied, thepatch retaining lines 512 may be cut, and/or one end of the patchretaining line 512 may be pulled to slide the patch retaining line 512out of the patch 600 and/or distal end of the insertion tool 500. Onceremoved, cut or otherwise released, the patch 600 may be slid off of thedistal retaining arm 504 within the patient.

Alternatively, as illustrated in FIGS. 41A to 41D, a patch insertiontool 500 may include a patch 600 secured between a distal retaining arm504 and a proximal retaining arm 506 adjacent to the elongated body 502wherein the patch retention line 512 may be threadedly received alongthe length of the patch 600. Particularly, the patch retention line 512may be secured to the proximal retention arm 506, then threaded througha first side of patch 600, then positioned in the distal retention arm504, then threaded through a second side of the patch 600, and thenagain placed onto the proximal retention arm 506.

To releasably secure the patch with retaining line 512, the distal patchretaining arm 504 defines at least one distal patch retaining linegroove 544 and the proximal patch retaining arm 506 defines at least oneproximal patch retaining line groove 546. The distal patch retainingline grooves 544 and the proximal patch retaining line groove 546 aregenerally configured to retain one or more patch retaining lines 512that have been threaded through a patch 600 one or more times. Theproximal patch retaining arm 506 is shown defining two proximal patchretaining line grooves 546 including one on each side of the retainingarm gap 516. As particularly shown in FIG. 41, a patch retaining line512 originating from the proximal end of the elongated body 502 may bereceived along a first proximal patch retaining line groove 546 and thenthrough a second proximal patch retaining line groove 546. The patchretention line 512 continues along a first side of patch 600 distallyapproximately parallel to the longitudinal axis of patch delivery tool500. The patch retaining line 512 is received within a first distalpatch retaining line groove 544 and then through a second distal patchretaining line groove 544. The patch retention line 512 continuesproximally along a second side of patch 600 approximately parallel tothe longitudinal axis of tool 500 and the distal end is secured with aknot to itself adjacent to the proximal patch retaining arm 506.Alternatively, the patch retaining line 512 may be otherwise secured atthe distal end of the insertion tool 500 or may extend proximally alongthe elongated body 502. To release the lines, the one or more knots inthe patch retaining line 512 may be untied, the patch retaining lines512 may be cut, and/or one end of the patch retaining line 512 may bepulled to slide the patch retaining line 512 out of the patch 600 and/ordistal end of the insertion tool 500. In the embodiment illustrated,patch retaining line 512 may be tightened or otherwise foreshortened bycinching slip knot 108. This process may follow the placement/deploymentof fixation apparatus 100 (or 309) by fixation delivery apparatus 400,and, in this illustrative embodiment, a portion of 512 may remain withthe patch once delivered. Alternatively, line 512 may be removed, cut orotherwise released, and patch 600 may be removed from the insertion tool500. Trailing line of line 512 may additionally be cut to length. Thoseskilled in the art would recognize multiple retention lines 512 could beused so as to secure patch 600 to tool 500.

An alternative embodiment as particularly illustrated in FIGS. 42A to42D, a patch insertion tool 500 may include a patch 600 secured betweena distal retaining arms 504 and a proximal retaining arms 506. The patchdelivery tool 500 as shown, may have at least one patch retention line512 threadedly received through a proximal portion 606 and a distalportion 604 of patch 600. Particularly, the patch retention line 512 maybe secured through the proximal retention arm 506 and the patchretention line 512 may be threaded through a proximal portion 606 ofpatch 600. The patch retention line 512 may then be threaded through adistal portion 604 of patch 600 and secured through the distal retentionarms 504. The patch retention line 512 may then be passed through theproximal retention arm 506 and secured or passed proximally. The patchretention line 512 is provided to secure the patch 600 to the distalpatch retaining arm 504 and to the proximal patch retaining arm 506. Thedistal patch retaining arm 504 defines at least one distal patchretaining line passage 534 and the proximal patch retaining arm 506defines at least one proximal patch retaining line passage 536 extendingthrough arms 504 and 506. The distal patch retaining line passages 534and the proximal patch retaining line passages 536 are generallyconfigured to receive one or more patch retaining lines 512 that havebeen threaded through a patch 600 one or more times. As illustrated, thedistal patch retaining arm 504 defines four proximal patch retainingline passages 534 including two on each side of the distal patchretaining arm gap 514. The proximal patch retaining arm 506 is showndefining four proximal patch retaining line passages 536 including twoon each side of the proximal patch retaining arm gap 516.

As shown in FIGS. 42A to 42D, a patch retaining line 512 may extendthrough a first proximal patch retaining line passage 536 and may thenbe threaded through a proximal portion 606 of the patch 600. The linemay then be threaded through another location in the proximal portion606 and passed through a second proximal patch retaining line passage536. The line may then be threaded through a third proximal patchretaining line passage 536 and then threaded through another location inthe proximal portion 606 of patch 600. The line may then be threadedthrough a another proximal patch retaining line passage 536. The line512 is then threaded through a location in the distal portion 604 andpassed through a first distal patch retaining line passage 534. The line512 is similarly threaded through the distal retaining arm 504 andassociated line passages 534 and distal portion 604 of patch 600 asshown in FIGS. 42B and 42D. The line is then directed proximally alongthe longitudinal axis of the elongated body 502. The retaining line 512may be secured at the distal end of the insertion tool 500 or, asillustrated for exemplary purposes, may extend proximally along theelongated body 502. To release the lines, one or more knots in the patchretaining line 512 may be untied, the patch retaining lines 512 may becut, and/or one end of the patch retaining line 512 may be pulled toslide the patch retaining line 512 out of the patch 600 and/or passages534, 536 of insertion tool 500. Once removed, cut or otherwise released,the patch 600 may be slid off of the distal retaining arm 504 and aproximal retaining arm 506 either simultaneously or sequentially.

Although the various descriptions and illustrations shown hereinexemplify a variety of ways and means to temporarily or releasablysecure a patch 600 to a delivery tool 500, those skilled in the artwould recognize that these are illustrative and are not intended to belimiting. Moreover, it is possible to use combinations of the securementmodalities described herein, or portions thereof, to effect the sameoutcomes.

Although the various embodiments illustrated herein of retaining arms504 and 506 of treatment delivery apparatus 500 show arms 504 and 506 ina fixed relationship with 500, one skilled in the art would recognizethat arms 504 and/or 506 could be rotatably or otherwise adjustable tochange the configuration of tool 500 as needed to accommodate delivery,deployment, affixation of patch 600 and/or removal of delivery tool 500.For example, arm 504 may have a hinged or otherwise articulatedrelationship with delivery tool 500 (not shown). In one exemplaryembodiment of an hinged arm 504, the projection of arm 504 from toolbody 502 may be more closely aligned with the elongated axis of toolbody 502 in a first configuration, such as delivery of patch to the discspace; whereas, during affixation of the patch, arm 504 could assume asecond configuration wherein arm 504 may be more perpendicular to theaxis of the body 502 (as is shown generally in the drawings). It is alsoanticipated that arm 506 (if present) could similarly be adjustable.Those skilled in the art would recognize this is exemplary and is notintended to be exhaustive of the various alternative configurations toprovide means for adjusting the emanation of arms 504 and 506 from toolbody 502.

The fixation delivery apparatus 400, fixation apparatus 100 (or, forexample, 309), treatment insertion tools 500 and patches 600 may be usedin a variety of procedures for repair, re-approximation, reinforcement,retention, reconstruction, or fixation of the intervertebral disc 200 orits components, such as the annulus 202. The fixation apparatus andpatch-like devices may be used together or as separate reparativeapparatuses in the repair of disc aberrations. In one exemplarymethodology, a patch 600 may be positioned within a defect in anintervertebral annulus with a patch insertion tool 500. A fixationapparatus 100 may then be secured in at least a portion of the patch 600and intervertebral disc using a fixation delivery apparatus 400, orother devices for securing fixation apparatus as disclosed herein and aswill be recognized by those skilled in the art upon review of thepresent disclosure to effect a repair, re-approximation, reinforcement,retention, reconstruction, or fixation of the intervertebral disc.

Steps of an exemplary embodiment of a method and devices to effect arepair are particularly illustrated in FIGS. 43A to 43E. As shown,distal portion 604 of the patch 600 may be secured to an inner surfaceof an annular defect and the proximal portion 606 may be secured to anouter surface of the intervertebral disc on the opposite side of theaperture. The patch 600, once positioned, may span a portion of theaperture. The fixation apparatus 100 may function to draw towards ortogether the tissues surrounding the defect or aperture, and may performthe reparative treatment cooperatively with the patch 600. The patch 600may also function to facilitate ingrowth of tissue or to otherwisefunction as indicated throughout this disclosure and as will berecognized by those skilled in the art upon review of the presentdisclosure.

As depicted in FIG. 43A, a patch 600 may be releasably secured over adistal portion of the patch insertion tool 500 such that the distalpatch retention arm 504 and a distal portion of the elongated body 502may be received within the patch mounting cavity 610 of the patch 600.The distal patch retention arm 504 is shown extending into the distalportion 604 of the patch 600 through patch mounting cavity 610. Thedistal portion of the insertion tool 500 with patch 600 may be insertedinto a cavity 212 within an intervertebral disc through an aperture 214in the intervertebral disc 200 of a patient. The treatment deliveryapparatus 500 is manipulated by a surgeon to position the distal portion604 of the patch 600 at a position in proximity or adjacent to an innersurface of the annulus 202 and/or cavity 212 of an intervertebral disc200 where it is to be secured.

After patch placement as depicted in 43B, fixation delivery apparatus400 may be inserted longitudinally along the patch delivery tool 500through the guide 508, through the patch retaining arm gap 516 of arm506, through disc tissue and, through the patch 600 positioned on thedistal portion of the patch delivery tool 500. The shaft 14, or othercomponent of the fixation delivery apparatus 400, may be advanced untilthe shaft 14 is positioned at a location where the physician desires todispense an anchor 102 of a fixation apparatus 100 and/or tissue stop 54restricts further penetration. Once positioned at the desired location,an anchor 102, such as the illustrated first anchor 112, may bedispensed from shaft 14 of apparatus 400. Once the first anchor 112 isdispensed, shaft 14 of apparatus 400 may be withdrawn from the firstlocation leaving the first anchor 112 of fixation apparatus 100 withinthe tissue and/or cavity of the intervertebral disc. As shown in FIG.43C, filament loop or eyelet 110 and elongate member 104 of the fixationapparatus 100 may extend from the intervertebral disc.

As depicted in 43C, the distal portion 504 of the insertion tool 500with patch 600 may then be positioned at an alternative locationproximate the annular aperture and at a desired position adjacent to anouter surface of the intervertebral disc, where it may be secured. Indoing so, the distal patch retaining arm 504 of the patch insertion tool500 may be repositioned within the patch mounting cavity 610 of thepatch 600 to locate the proximal portion 606 of the patch 600 over thedistal patch retaining arm 504. The distal end of shaft 14, or othercomponents of tool 400, may be inserted through the proximal portion 606of patch 600 through the distal patch retaining arm gap 514 of thedistal patch retaining arm 504. The shaft 14 of a fixation deliveryapparatus 400 may then be inserted through disc tissue at a secondlocation as desired by the surgeon. The shaft 14 of the fixationdelivery apparatus 400 may again be advanced until the shaft 14 ispositioned at a location where the physician desires to dispense ananchor 102 of a fixation apparatus 100. Once positioned at the desiredlocation, an anchor 102, such as the illustrated second anchor 122, maybe dispensed from shaft 14. Once the second anchor 122 is dispensed, theshaft 14 of the fixation delivery apparatus 400 may be withdrawn fromthe second location leaving the second anchor 122 of the fixationapparatus 100 within the cavity and/or tissue (such as the annulus ornucleus) of the intervertebral disc. Eyelets 110 and bands 104 of thefixation apparatus 100 may extend from the intervertebral disc and/orthe patch 600.

As depicted in FIG. 43D, fixation delivery apparatus 400 is withdrawnfrom the intervertebral disc and patch 600, leaving the fixationapparatus 100 in a loose, unclenched, or untightened configurationsecured through the patch 600 and disc tissue. The distal patchretaining arm 504 is also removed from the patch mounting cavity 610 ofthe patch 600. A cinch line 124 of the fixation apparatus 100 may extendfrom the intervertebral disc to a location where it may be accessed bythe surgeon. As illustrated, the elongated member 104 is secured in acinchable loop by a retention device 108 in the form of a slip knot,although other band retention or locking devices as previously describedmay be used. The loop formed by the elongated member 104 extends throughloops 110 which are affixed to the anchors 102. Although FIG. 43 shows afixation device comprising eyelets and looped bands, those skilled inthe art would realize that alternative elongate member configurationscould be used to effect the same purpose. As shown in FIG. 43E, the loopmay be cinched or tightened by sliding the retention device 108 alongthe elongated member 104. This cinching or tightening draws the bandportions (110 and 104) between anchors 102 together and may reparativelyretain, stabilize, re-approximate or otherwise repair tissuessurrounding a defect and/or aperture by drawing tissues towards oneanother and/or against the patch 600. Patch 600 may act as a filler tofill a defect in the intervertebral disc.

Steps of another exemplary method are particularly illustrated in FIGS.44A to 44E. As illustrated, a patch 600 may be positioned through anaperture in an intervertebral disc in a C-type configuration and mayhave patch delivery devices as previously described, for example inFIGS. 34 and 42. In the illustrated method of FIGS. 44A to 44E, thedistal portion 604 of patch 600 may be secured to an inner portion of anintervertebral disc (such as an inner portion of the annulus) and theproximal portion 606 may be secured to an outer surface of theintervertebral disc. As illustratively shown, ends of patch 600 may begenerally placed on the same medial-lateral side of aperture 214,although this is illustrative and not intended to be limiting A fixationapparatus 100 (or 309) may be used to secure the patch to theintervertebral disc. The fixation apparatus 100 may also draw togetheror otherwise enable closure of the annular aperture or defect of theintervertebral disc. The patch 600, once positioned, may extend from theaperture and may function to permit closure of the aperture, tofacilitate the ingrowth of tissue, and/or to otherwise function asindicated throughout this disclosure and as will be recognized by thoseskilled in the art upon review of the present disclosure.

As depicted in FIG. 44A, a patch 600 is releasably secured to a distalportion of the mesh delivery apparatus 500. Device 600 is securedbetween the distal retention arm 504 and the proximal patch arm 506. Thedistal retention arm 504 is shown releasably securing the distal portion604 of device 600. The proximal retention arm 506 is shown releasablysecuring the proximal portion 606 of device 600. The overallconfiguration of the device resembles a “C” in cross-section, openingaway from the elongated body 502 of the patch insertion tool 500. Thedistal portion of the patch insertion tool 500 with patch 600 may beinserted into a cavity within an intervertebral disc through an aperturein the intervertebral disc of a patient. The patch insertion tool 500may be manipulated by a surgeon to position the distal portion 604 ofthe patch 600 at a position adjacent to an inner surface of disc tissuewithin a cavity of an intervertebral disc where the patch may be securedand the proximal portion 606 of the patch 600 at a position adjacent toan outer surface of an intervertebral disc, where the patch may also besecured. As illustrated, the proximal portion 606 and the distal portion604 of the device 600 may be configured to be secured on the samemedial-lateral side of an annular aperture, although it is possible thatit could also be placed cephalad-caudally, or in alternative positionalconfigurations.

As depicted in 44B, a shaft 14, or components of a fixation deliveryapparatus 400, may be inserted longitudinally along the patch deliverytool 500 through guides 508 and then through the proximal retaining armgap 516 of the proximal retaining arm 506 and up to the patch 600,secured on the distal portion of the patch delivery tool 500. The distalend of shaft 14 may be then inserted through the proximal portion 606 ofpatch 600 and through intervertebral disc tissue at a first location andthen may continue to be inserted through the distal portion 604 ofdevice 600 through the distal retaining arm gap 514 of the distalretaining arm 504. Fixation delivery apparatus 400 may be advanced untilthe shaft 14 is positioned at a location where the physician desires todispense an anchor 102 of a fixation apparatus 100. Once positioned atthe desired location, an anchor 102, such as the illustrated firstanchor 112, may be dispensed from shaft 14. Once the first anchor 112 isdispensed, the shaft 14 of the fixation delivery apparatus 400 may bewithdrawn from the first location leaving the first anchor 112 of thefixation apparatus 100 within disc tissue, cavity, and/or device 600.Portions of fixation apparatus 100 may extend from the device 600 and/orthe intervertebral disc.

As depicted in 44C, insertion tool 500 may be released from patch 600and may then be removed from the intervertebral disc. The shaft 14 of afixation delivery apparatus 400 may then be inserted through theintervertebral disc at a second location as desired by the surgeon,which as illustrated, may be located at an opposing side of an aperturefrom the first location. The shaft 14 of the fixation delivery apparatus400 may again be advanced until the shaft 14 is positioned at a locationwhere the physician desires to dispense an anchor 102 of a fixationapparatus 100. Once positioned at the desired location, an anchor 102,such as the illustrated second anchor 122, may be dispensed from thelumen 24 and/or slit 34 of shaft 14. Once the second anchor 122 isdispensed, the shaft 14, or other components of the fixation deliveryapparatus 400, may be withdrawn from the second location, leaving thesecond anchor 122 of the fixation apparatus 100 within disc tissue,and/or the cavity of the intervertebral disc and leaving portions offixation apparatus 100, such as band 104 and 110 extending from and/orthrough the intervertebral disc.

As depicted in FIG. 44D, the shaft 14 of the fixation delivery apparatus400 may then be withdrawn from the intervertebral disc, leaving thefixation apparatus 100 in a loose or uncinched configuration whilesecured into and/or through the patch 600 and wholly or partially acrossthe annular aperture in the intervertebral disc. A cinch line 124 of thefixation apparatus 100 may extend from the intervertebral disc to alocation where it may be accessed by the surgeon. As illustrated, theelongated member 104 may be, for exemplary purposes, secured in acinchable loop by a retention device 108 in the form of a slip knot. Theloop formed by the elongated member 104 may extend through eyelets 110which are secured to the anchors 102. As shown in FIG. 44E, the loop maybe cinched or tightened by sliding the retention device along theelongated member 104. The cinching or tightening of band 104 may drawtogether the tissue and the devices surrounding an annular defect andmay also effect approximation. Moreover, cinching may further drawanchors into annular tissues. As illustrated, band 104 may be cinched ortightened until the tissues surrounding the aperture and/or defect aredrawn towards one another and/or the patch 600, reducing the size of theaperture and/or closing the defect in the intervertebral disc.

Although patch 600 has been illustrated in FIGS. 38 to 46 as having asingle configuration/construction, there may be a multitude ofconfigurations/constructions of patches, including patches that maycomprise additional elongate elements, such as sutures, to accommodatedelivery and deployment of devices to affect annular repair. FIG. 45Ashows various alternative configurations of patches 600 that may alsoinclude patch tethers 612 to attach the patch to delivery tools 500, aswell as to facilitate affixation of the patch to disc tissue. Tethers612 may be fixed in shape or may be advantageously cinchable with memberretention devices 108, such as slip knots. Patch tethers as illustratedmay be present on the distal, proximal or both portions of the patch.Tethers in proximity of the exterior of the annulus may advantageouslycause less of an inflammatory tissue response than that of largerpatch-like devices.

Steps of another exemplary method are particularly illustrated in FIGS.45A to 45F, wherein more than one patch may utilized in a repair. Asillustrated, two patches 600 may be positioned in an intervertebral discin a Double C-type configuration. In the illustrated method of FIGS. 45Ato 45F, the distal portions 604 of the first patch 600 and the secondpatch 600 may be secured to an inner aspect of an intervertebral discand the proximal portions 606 of the first patch 600 and the secondpatch 600 may be secured to an outer aspect of an intervertebral disc.The fixation apparatus 100 may secure one or more of the first andsecond patches 600 to tissues surrounding an annular aperture in theintervertebral disc. The fixation apparatus 100 may also enable drawingtowards one another these tissues and/or patches so as to accommodateclosure the aperture and/or defect. The first and second patches 600,once secured, may extend through the aperture, may function to permitclosure of the aperture, may facilitate ingrowth of tissue or mayotherwise function as indicated throughout this disclosure and as willbe recognized by those skilled in the art upon review of the presentdisclosure.

As depicted in FIG. 45A, a first patch 600 may be releasably secured toa distal portion of the patch insertion tool 500. The first patch 600 issecured between the distal patch retention arm 504 and the proximalpatch retention arm 506. The distal patch retention arm 504 is shownsecured to the distal portion 604 of the first patch 600. The proximalpatch retention arm 506 is shown secured to the proximal portion 606 offirst patch 600. The overall configuration of the patch resembles a “C”in transverse cross- section opening away from the elongated body 502 ofthe patch insertion tool 500. The patch insertion tool 500 may bemanipulated by a surgeon to position the distal portion 604 of the firstpatch 600 at a position adjacent to an inner surface of a cavity of anintervertebral disc and the proximal portion 606 of the first patch 600at a position adjacent to an outer surface of an intervertebral discwhere the first patch 600 is to be secured.

As depicted in 45B, a shaft 14, or components of a fixation deliveryapparatus 400, may be inserted longitudinally along the patch deliverytool 500 through guide 508 and then through the proximal patch retainingarm gap 516 of the proximal patch retaining arm 506 up to the firstpatch 600 secured on the distal portion of the patch delivery tool 500.The distal end of the shaft 14 may be inserted through the proximalportion 606 of first patch 600 and then inserted into the intervertebraldisc tissue at a first location, as desired by the surgeon. The distalend of the shaft 14 may be then inserted through the distal portion 604of first patch 600 through the distal patch retaining arm gap 514 of thedistal patch retaining arm 504. The shaft 14, or components of thefixation delivery apparatus 400, may be advanced until the shaft 14 ispositioned at a location where the physician desires to dispense ananchor 102 of a fixation apparatus 100 (or 308, not shown). Oncepositioned at the desired location, an anchor 102, such as theillustrated first anchor 112, may be dispensed from the lumen 24 and/orslot 34 of the shaft 14. Once the first anchor 112 is dispensed, theshaft 14 of the fixation delivery apparatus 400 may be withdrawn fromthe first location leaving the first anchor 112 of the fixationapparatus 100 within the intervertebral disc and portions of thefixation apparatus 100 extending through the first patch 600 and theintervertebral disc.

As depicted in FIG. 45C, a second patch 600 may then be providedreleasably secured to a distal portion of patch insertion tool 500. Thesecond patch 600 may also be secured between the distal patch retentionarm 504 and the proximal patch retention arm 506 and placed at leastpartially within the intervertebral disc. The patch insertion tool 500may be manipulated by a surgeon so as to guide where the second patch600 is to be secured. As illustrated, both the proximal portion 606 andthe distal portion 604 of the second patch 600 may be configured to besecured on a second side of an aperture extending into theintervertebral disc.

As depicted in 45D, a shaft 14 of a fixation delivery apparatus 400 mayagain be inserted longitudinally along the patch delivery tool 500through the guide 508, through the proximal portion 606 of patch 600,through the intervertebral disc tissue, and through the distal portion604 of second patch 600. The shaft 14 of the fixation delivery apparatus400 is advanced until the shaft 14 is positioned at a location where thephysician desires to dispense an anchor 102 of a fixation apparatus 100(or, for example, 308). Once positioned at the desired location, ananchor 102, such as the illustrated second anchor 122, is dispensed fromthe lumen 24 and/or slot 34 of shaft 14. Once the second anchor 122 isdispensed, the shaft 14 of the fixation delivery apparatus 400 may bewithdrawn from the second location.

As depicted in FIG. 45E, the shaft 14 of the fixation delivery apparatus400 may then be withdrawn from the intervertebral disc leaving thefixation apparatus 100 in a loose or uncinched configuration securedthrough the first patch 600, across the aperture in the intervertebraldisc, and through the second patch 600. It should be noted thatplacement of fixation devices, such as 308, with device deliveryapparatuses 400 may result in separate anchor bands being placed andcinched into each patch 600 and an additional elongate member 104connecting the two anchor bands 308 and/or patches 600 may be utilizedto draw towards one another the patches and the surrounding disc tissue.In an alternative embodiment using fixation apparatuses 100, anadditional cinchable elongate member 104 may be secured to each patchand drawing on cinch line 124 may further draw together the two patches.It is also conceivable to place and secure more than two patches in asimilar fashion.

Continuing with illustrated apparatus 100 of FIG. 45E, a cinch line 124may extend from the intervertebral disc to a location where it may beaccessed by the surgeon. As illustrated, the elongated member 104 mayagain be, for exemplary purposes, secured in a cinchable loop by aretention device 108 in the form of a slip knot. The loop formed by theelongated member 104 may pass through loops 110 attached to anchors 102.As shown in FIG. 45F, the loop may be cinched or tightened by slidingthe retention device along the elongated member 104. As previouslydescribed, cinching or tightening may draw the edges of the aperturetoward one another and/or against the first and second patches 600,reducing the size of the aperture and/or closing the defect in theintervertebral disc.

Steps of yet another exemplary method are particularly illustrated inFIGS. 46A to 46F. As illustrated, a patch 600 may be secured across anaperture in a linear-type configuration. In the illustrated method ofFIGS. 46A to 46F, the distal portion 604 of the patch 600 may be securedto an inner surface of an intervertebral disc and the proximal portion606 may be secured to an inner surface of the intervertebral disc on theopposite side of an aperture and/or defect. The patch 600, oncepositioned may span the defect or aperture. The fixation apparatus 100may additionally facilitate drawing together and/or closing the defect.The patch 600 may cooperate with the fixation apparatus in closing theaperture. In addition or alternatively, the patch 600 may function tofacilitate in growth of tissue and/or to otherwise function as indicatedthroughout this disclosure and as will be recognized by those skilled inthe art upon review of the present disclosure.

As depicted in FIG. 46A, a patch 600 may be releasably secured over adistal portion of patch insertion tool 500 such that the distal patchretention arm 504 and a distal portion of the elongated body 502 arereceived within the patch mounting cavity 610 of the patch 600. Thedistal patch retention arm 504 is shown having a collapsibleconfiguration where the distal patch retention arm 504 is foldablebetween a perpendicular and a longitudinal orientation. Theperpendicular orientation, for example, may permit the simplifiedintroduction of a fixation apparatus 100 and/or portions fixationdelivery apparatus 400, thereof, through the patch 600. The longitudinalorientation, for example, may permit the simplified introduction ofapparatus 500 with patch 600 through an aperture in an intervertebraldisc. As illustrated, each opposing lateral portion of the distal patchretention arm may extend into a patch mounting cavity 610 of the patch600. The distal portion of the insertion tool 500 with patch 600 isinserted into a cavity within an intervertebral disc through an aperturein the intervertebral disc of a patient with both opposing lateralportions folded distally (as shown) or proximally (not shown) in anorientation substantially along a longitudinal axis of the elongatedbody 502. The patch insertion tool 500 is manipulated by a surgeon toposition in an intervertebral disc tissue where it is to be secured.

As depicted in 46B lateral portions may extend outwardly from insertiontool 500 once patch 600 is positioned within and/or on surrounding disctissue, and a shaft 14, or components of a fixation delivery apparatus400, may be inserted longitudinally along patch delivery tool 500. Thedistal end of the shaft 14 is passed into or through intervertebral disctissue at a first location as desired by the surgeon. The distal end ofthe shaft 14 may then be inserted through the distal portion 604 ofpatch 600. The shaft 14 of fixation delivery apparatus 400 may beadvanced until the shaft 14 is positioned at a location where thephysician desires to dispense an anchor 102 of a fixation apparatus 100(or, for example 308). Once positioned at the desired location, ananchor 102, such as the illustrated first anchor 112, is dispensed fromshaft 14. Once the first anchor 112 is dispensed, the shaft 14 of thefixation delivery apparatus 400 is withdrawn from the first locationleaving the first anchor 112 of the fixation apparatus 100 within theintervertebral disc.

As depicted in 46C, the distal portion of the insertion tool 500 withpatch 600 may then be positioned within the disc to position theproximal portion 606 of the patch 600 at a desired location where it isto be secured. In doing so, the proximal patch retaining arm 506 of thepatch insertion tool 500 may be repositioned within the cavity of theintervertebral disc to locate the proximal portion 606 of the patch 600at a second location proximate an aperture or defect. The shaft 14 of afixation delivery apparatus 400 may then be inserted through theintervertebral disc at a second location, as desired by the surgeon, andpassed through a proximal portion 606 of patch 600 on the proximal patchretaining arm 506. The shaft 14 of the fixation apparatus fixationdelivery apparatus 400 may again be advanced until the shaft 14 ispositioned at a location where the physician desires to dispense asecond anchor 122 of a fixation apparatus 100. Once positioned at thedesired location, an anchor 102, such as the illustrated second anchor122, is dispensed from shaft 14. Once the second anchor 122 isdispensed, the shaft 14 of the fixation delivery apparatus 400 may bewithdrawn from the second location, leaving the second anchor 122 of thefixation apparatus 100 within the intervertebral disc.

As depicted in FIGS. 46D, 46E, and 46F, patch delivery apparatus 500 maythen be withdrawn from the intervertebral disc. To withdraw the patchinsertion tool 500, the lateral aspects of the distal patch retentionarm 504 may be collapsed into a longitudinal orientation for withdrawalfrom the patch mounting cavity 610 of patch 600 and/or withdrawalthrough the aperture in the intervertebral disc. Once withdrawn, thepatch 600 may be left secured to the inner surface of an intervertebraldisc with fixation apparatus 100 in a loose or uncinched configuration.A cinch line 124 of the fixation apparatus 100 may extend from theintervertebral disc to a location where it may be accessed by thesurgeon. As illustrated, the elongated member 104 is secured in acinchable loop by a retention device 108 in the form of a knot. The loopformed by the elongated member 104 may extend through the eyelets 110which are secured to anchors 102. As shown in FIG. 46F, the loop may becinched or tightened by sliding the retention device along the elongatedmember 104. As previously described, cinching or tightening eyelets 110together tends to draw the first anchor 112 and the second anchor 122toward the inner surface of the intervertebral disc. As illustrated, theloop may draw together toward one another the tissue surrounding theaperture and patch material, and may reduce the size of and/or close theannular defect.

It should also be noted that those skilled in the art, upon review ofthe present disclosure, will recognize that the described apparatus,delivery tools and patches or portions thereof may be rendered visibleor more visible via fluoroscopy, if desired, through the incorporationof radio-opaque materials or markers. In one aspect, the implantabledevices are constructed with magnetic resonance imaging (MRI) compatiblematerials. In particular, devices and/or their components could bewholly or partially radiopaque, as result of, for example: compoundingvarious radiopaque materials (e.g., barium sulphate) into devicematerials; affixing radiopaque materials to device structures (e.g.,bands of platinum, gold, or their derivative alloys); deposition ofradiopaque materials onto device structures (e.g., deposition ofplatinum, gold of their derivative alloys); processing radiopaquematerials into device structures (e.g., braiding/weaving platinum orgold wires or its alloy derivatives).

Other embodiments of the invention will be apparent to those skilled inthe art after consideration of this disclosure and practice of theinventions disclosed herein. It is intended that this specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. A method of anchoring an implant to tissue of a patient, the methodcomprising: providing a delivery apparatus releasably carrying afixation apparatus, the delivery apparatus including a body, a tubularshaft extending from the body and having a distal end, a displacementrod longitudinally displaceable within the body and the tubular shaftand including a proximal end and a distal end, and an actuator coupledto the body and attached to the proximal end of the displacement rod,the fixation apparatus including first and second anchors, a flexibleband connecting the first and second anchors and including a cinch linereleasably coupled to the delivery apparatus, and a tether having aproximal end attached to the delivery apparatus and a distal endattached to the second anchor; positioning the implant in proximity tothe tissue; inserting the distal end of the tubular shaft into orthrough the tissue at a first location; operating the actuator to deploythe first anchor into or through the tissue; relocating the deliveryapparatus to a second location different than the first location, thesecond location selected such that at least a portion of the implant islocated between the band and the tissue; inserting the distal end of thetubular shaft into or through the tissue at the second location;operating the actuator to deploy the second anchor into or through thetissue; applying tension to the cinch line to foreshorten the bandbetween the first and second anchors, thereby securing the implant tothe tissue with the at least a portion of the implant positioned betweenthe band and the tissue.
 2. The method of claim 1 wherein the fixationapparatus includes a first suture connected to the first anchor, aseparate, second suture connected to the second anchor, and wherein theband includes a separate, third suture coupled to the first and secondsutures, the third suture forming a suture loop having an adjustablelength, and wherein applying tension to the cinch line foreshortens theadjustable length of the suture loop.
 3. The method of claim 2 whereinthe first and second sutures are each in the form of a suture loop, andwherein the third suture extends through the loops formed by the firstand second sutures such that the first and second anchors are slidablycoupled to the third suture.
 4. The method of claim 1 wherein thedelivery apparatus further includes a system for regulating movement ofthe actuator and the displacement rod.
 5. The method of claim 4 whereinoperating the actuator to deploy the first anchor includes advancing theactuator and the displacement rod a first distance so as to eject thefirst anchor from the distal end of the tubular shaft, and wherein thetether is operable to resist expulsion of the second anchor from thetubular shaft during deployment of the first anchor.
 6. The method ofclaim 5 wherein operating the actuator to deploy the second anchorincludes advancing the actuator and the displacement rod a seconddistance so as to eject the second anchor from the distal end of thetubular shaft.
 7. The method of claim 6 wherein operating the actuatorto deploy the second anchor includes severing the tether so that thetether does not resist ejection of the second anchor from the distal endof the tubular shaft.
 8. The method of claim 1 wherein the tetherextends through the tubular shaft, and wherein the proximal end of thetether is attached to the delivery apparatus within the body of thedelivery apparatus.
 9. The method of claim 8 wherein the deliveryapparatus includes a tether severing element in the body including acutting edge, and wherein operating the actuator to deploy the secondanchor includes severing the tether by the cutting edge.
 10. The methodof claim 1 wherein the delivery apparatus includes a guide extendinginto the body, a guide spring biasing the guide toward the actuator, anddisplacement spring in the body biasing the displacement rod in aproximal direction and away from the distal end of the tubular shaft,and wherein the actuator includes a groove, and wherein the guideextends into and is slidably received by the groove so as to regulatemovement of the actuator and the displacement rod.
 11. The method ofclaim 10 wherein the groove includes a first longitudinally extendingportion having a first length, and a second longitudinally extendingportion having a second length, and wherein operating the actuator todeploy the first anchor includes advancing the actuator a first distancecorresponding to the first length, and wherein operating the actuator todeploy the second anchor includes advancing the actuator a seconddistance corresponding to the second length.
 12. The method of claim 10wherein the groove further includes a radially extending portion betweenthe first and second longitudinally extending portions, and wherein themethod further comprises rotating the actuator relative to the bodyafter advancing the actuator the first distance.
 13. The method of claim12 wherein advancing the actuator the second distance is performed afterrotating the actuator relative to the body.
 14. The method of claim 13wherein advancing the actuator the second distance causes the tetherline to be severed within the body.
 15. The method of claim 14 furthercomprising removing excess lengths of the tether and the cinch line. 16.The method of claim 1 wherein the implant is a therapeutic device. 17.The method of claim 16 wherein the implant is an orthopedic device. 18.The method of claim 17 wherein the orthopedic device is a meshconfigured to repair a defect in an annulus of an intervertebral disc.19. A method of anchoring an implant to tissue of a patient, the methodcomprising: providing a delivery apparatus releasably carrying afixation apparatus, the delivery apparatus including a body, a tubularshaft extending from the body and having a distal end, a displacementrod longitudinally displaceable within the body and the tubular shaftand including a proximal end and a distal end, and an actuator coupledto the body and attached to the proximal end of the displacement rod,the fixation apparatus including first and second anchors, a firstsuture connected to the first anchor, a separate, second sutureconnected to the second anchor, and a flexible band connecting the firstand second anchors and including a separate, third suture coupled to thefirst and second sutures and forming an adjustable suture loop and acinch line releasably coupled to the delivery apparatus; positioning theimplant in proximity to the tissue; inserting the distal end of thetubular shaft into or through the tissue at a first location; operatingthe actuator to deploy the first anchor into or through the tissue;relocating the delivery apparatus to a second location different thanthe first location, the second location selected such that at least aportion of the implant is located between the band and the tissue;inserting the distal end of the tubular shaft into or through the tissueat the second location; operating the actuator to deploy the secondanchor into or through the tissue; applying tension to the cinch line toforeshorten the adjustable suture loop between the first and secondanchors, thereby securing the implant to the tissue with the at least aportion of the implant positioned between the adjustable suture loop andthe tissue.
 20. The method of claim 19 wherein the first and secondsutures are each in the form of a suture loop, and wherein the thirdsuture extends through the loops formed by the first and second suturessuch that the first and second anchors are slidably coupled to the thirdsuture.